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    Clinical Trial Results:
    An open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants

    Summary
    EudraCT number
    		 2019-001699-12
    Trial protocol
    		 GB  
    Global end of trial date
    17 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Aug 2020
    First version publication date
    06 Aug 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    205019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@GSK.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000434-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the relative bioavailability of ambrisentan (AMB, [1 milligram (mg) x 5 tablets] administered as tablets dispersed in water or administered orally, with marketed AMB (5 mg x 1 tablet) administered orally, in healthy adult participants under fasted conditions
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was a single center, open-label, randomized, single dose, 3-period crossover study in healthy participants that compared the pharmacokinetics (PK) of a new lower dose formulation (dispersed in water and administered intact orally) of ambrisentan (AMB) tablet with the reference marketed AMB tablet (administered orally).

    Pre-assignment
    Screening details
    		 A total of 29 participants were enrolled at a single center in the United Kingdom.

    Period 1
    Period 1 title
    Period 1 (4 days) + Washout (7days)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMB dispersed in water/AMB oral tablet/reference AMB
    Arm description
    		 Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 AMB oral tablet/reference AMB/AMB dispersed in water
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 Reference AMB/AMB dispersed in water/AMB oral tablet
    Arm description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 AMB dispersed in water/reference AMB/AMB oral tablet
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 AMB oral tablet/AMB dispersed in water/reference AMB
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 Reference AMB/AMB oral/AMB dispersed in water
    Arm description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Number of subjects in period 1
    		AMB dispersed in water/AMB oral tablet/reference AMB AMB oral tablet/reference AMB/AMB dispersed in water Reference AMB/AMB dispersed in water/AMB oral tablet AMB dispersed in water/reference AMB/AMB oral tablet AMB oral tablet/AMB dispersed in water/reference AMB Reference AMB/AMB oral/AMB dispersed in water
    Started
    4
    5
    5
    5
    5
    5
    Completed
    3
    4
    4
    5
    5
    5
    Not completed
    1
    1
    1
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
         Met Protocol defined Stopping Criteria
    -
    1
    -
    -
    -
    -
    Period 2
    Period 2 title
    Period 2 (4 days) + Washout (7days)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMB dispersed in water/AMB oral tablet/reference AMB
    Arm description
    		 Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 AMB oral tablet/reference AMB/AMB dispersed in water
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 Reference AMB/AMB dispersed in water/AMB oral tablet
    Arm description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 AMB dispersed in water/reference AMB/AMB oral tablet
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 AMB oral tablet/AMB dispersed in water/reference AMB
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 Reference AMB/AMB oral/AMB dispersed in water
    Arm description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Number of subjects in period 2
    		AMB dispersed in water/AMB oral tablet/reference AMB AMB oral tablet/reference AMB/AMB dispersed in water Reference AMB/AMB dispersed in water/AMB oral tablet AMB dispersed in water/reference AMB/AMB oral tablet AMB oral tablet/AMB dispersed in water/reference AMB Reference AMB/AMB oral/AMB dispersed in water
    Started
    3
    4
    4
    5
    5
    5
    Completed
    3
    4
    2
    5
    4
    5
    Not completed
    0
    0
    2
    0
    1
    0
         Adverse event, non-fatal
    -
    -
    -
    -
    1
    -
         Met Protocol defined Stopping Criteria
    -
    -
    2
    -
    -
    -
    Period 3
    Period 3 title
    Period 3 (4 days) + Follow-up (14 days)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMB dispersed in water/AMB oral tablet/reference AMB
    Arm description
    		 Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 AMB oral tablet/reference AMB/AMB dispersed in water
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 Reference AMB/AMB dispersed in water/AMB oral tablet
    Arm description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 AMB dispersed in water/reference AMB/AMB oral tablet
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Arm title
    		 AMB oral tablet/AMB dispersed in water/reference AMB
    Arm description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Arm title
    		 Reference AMB/AMB oral/AMB dispersed in water
    Arm description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMB oral tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were orally administered with 5 intact tablets of 1 mg unit dose.

    Investigational medicinal product name
    AMB dispersed in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB tablets were available at a unit dose strength of 1 mg. Participants were administered with 5 tablets of 1 mg unit dose dispersed in water.

    Investigational medicinal product name
    Reference AMB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AMB reference tablet were available as film-coated tablet at unit dose strength of 5 mg. Participants were orally administered with 1 tablet of 5 mg unit dose

    Number of subjects in period 3
    		AMB dispersed in water/AMB oral tablet/reference AMB AMB oral tablet/reference AMB/AMB dispersed in water Reference AMB/AMB dispersed in water/AMB oral tablet AMB dispersed in water/reference AMB/AMB oral tablet AMB oral tablet/AMB dispersed in water/reference AMB Reference AMB/AMB oral/AMB dispersed in water
    Started
    3
    4
    2
    5
    4
    5
    Completed
    3
    4
    2
    5
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1 (4 days) + Washout (7days)
    Reporting group description
    		 Participants received a single oral dose of AMB tablet (administered as 5 x 1 mg tablet) dispersed in water (F1) or a single dose of AMB oral tablet (administered as 5 x 1 mg tablet)administered intact (F2) or a single oral dose of reference AMB tablet (R) administered as 1 x 5 mg tablet in the following six sequences F1/F2/R, F2/R/F1, R/F1/F2, F1/R/F2, F2/F1/R and R/F2/F1.

    Reporting group values
    		 Period 1 (4 days) + Washout (7days) Total
    Number of subjects
    		 29 29
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 29 29
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 42.3 ( 11.16 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 2 2
        Male
    		 27 27
    Race/Ethnicity, Customized
    Units: Subjects
        Asian – Central/South Asian Heritage
    		 2 2
        Asian – East Asian Heritage
    		 1 1
        White – Arabic/North African Heritage
    		 1 1
        White – White/Caucasian/European Heritage
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    AMB dispersed in water/AMB oral tablet/reference AMB
    Reporting group description
    		 Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB oral tablet/reference AMB/AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    Reference AMB/AMB dispersed in water/AMB oral tablet
    Reporting group description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB dispersed in water/reference AMB/AMB oral tablet
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB oral tablet/AMB dispersed in water/reference AMB
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    Reference AMB/AMB oral/AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Reporting group title
    AMB dispersed in water/AMB oral tablet/reference AMB
    Reporting group description
    		 Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB oral tablet/reference AMB/AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    Reference AMB/AMB dispersed in water/AMB oral tablet
    Reporting group description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB dispersed in water/reference AMB/AMB oral tablet
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB oral tablet/AMB dispersed in water/reference AMB
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    Reference AMB/AMB oral/AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
    Reporting group title
    AMB dispersed in water/AMB oral tablet/reference AMB
    Reporting group description
    		 Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB oral tablet/reference AMB/AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    Reference AMB/AMB dispersed in water/AMB oral tablet
    Reporting group description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB dispersed in water/reference AMB/AMB oral tablet
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    AMB oral tablet/AMB dispersed in water/reference AMB
    Reporting group description
    		 Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Reporting group title
    Reference AMB/AMB oral/AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.

    Subject analysis set title
    AMB dispersed in water
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of 5 mg AMB tablet dispersed in water and administered orally

    Subject analysis set title
    AMB oral tablet
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of 5 mg AMB tablet administered intact orally

    Subject analysis set title
    Reference AMB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of reference 5 mg AMB tablet administered orally

    Subject analysis set title
    AMB dispersed in water
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of 5 mg AMB tablet dispersed in water and administered orally

    Subject analysis set title
    AMB oral tablet
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of 5 mg AMB tablet administered intact orally

    Subject analysis set title
    Reference AMB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of reference 5 mg AMB tablet administered orally

    Subject analysis set title
    AMB dispersed in water
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of 5 mg AMB tablet dispersed in water and administered orally

    Subject analysis set title
    AMB oral tablet
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of 5 mg AMB tablet administered intact orally

    Subject analysis set title
    Reference AMB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of reference 5 mg AMB tablet administered orally

    Primary: Maximum observed plasma concentration (Cmax) after administration of AMB under fasted condition

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    End point title
    		 Maximum observed plasma concentration (Cmax) after administration of AMB under fasted condition
    End point description
    Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who provided PK parameter data. Only those participants with data available at the specified data points were analysed.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [1]
    25 [2]
    26 [3]
    Units: Nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    359.030 ( 15.5 )
    316.505 ( 19.2 )
    353.252 ( 29.3 )
    Notes
    [1] - PK Parameter Population.
    [2] - PK Parameter Population.
    [3] - PK Parameter Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented
    Comparison groups
    Reference AMB v AMB dispersed in water
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of adjusted geometric mean
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.11
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented
    Comparison groups
    AMB oral tablet v Reference AMB
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of adjusted geometric mean
    Point estimate
    0.91
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 0.98

    Primary: Time to Cmax (Tmax) after administration of AMB under fasted condition

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    End point title
    		 Time to Cmax (Tmax) after administration of AMB under fasted condition [4]
    End point description
    Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified data points were analysed.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this endpoint.
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [5]
    25 [6]
    26 [7]
    Units: Hour
        median (full range (min-max))
    1.000 (0.50 to 2.00)
    2.000 (1.00 to 4.00)
    1.750 (0.50 to 8.00)
    Notes
    [5] - PK Parameter Population.
    [6] - PK Parameter Population.
    [7] - PK Parameter Population.
    No statistical analyses for this end point

    Primary: Time of last quantifiable concentration (tlast) after administration of AMB under fasted condition

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    End point title
    		 Time of last quantifiable concentration (tlast) after administration of AMB under fasted condition [8]
    End point description
    Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified data points were analysed.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this endpoint.
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [9]
    25 [10]
    26 [11]
    Units: Hour
        median (full range (min-max))
    72.00 (71.5 to 72.4)
    72.00 (71.5 to 72.1)
    72.00 (71.5 to 72.2)
    Notes
    [9] - PK Parameter Population.
    [10] - PK Parameter Population.
    [11] - PK Parameter Population.
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [(AUC(0-inf)] after administration of AMB under fasted condition

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    End point title
    		 Area under the plasma concentration-time curve from time zero extrapolated to infinite time [(AUC(0-inf)] after administration of AMB under fasted condition
    End point description
    Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified data points were analysed.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    23 [12]
    19 [13]
    22 [14]
    Units: Hours*nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    3006.443 ( 23.6 )
    2859.283 ( 21.7 )
    2963.908 ( 21.6 )
    Notes
    [12] - PK Parameter Population.
    [13] - PK Parameter Population.
    [14] - PK Parameter Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented
    Comparison groups
    AMB dispersed in water v Reference AMB
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of adjusted geometric mean
    Point estimate
    1.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.09
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented
    Comparison groups
    AMB oral tablet v Reference AMB
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of adjusted geometric mean
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.08

    Primary: Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration [AUC(0-t)] after administration of AMB under fasted condition

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    End point title
    		 Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration [AUC(0-t)] after administration of AMB under fasted condition
    End point description
    Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified data points were analysed.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27
    25
    26
    Units: Hours*nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    2844.151 ( 22.1 )
    2849.378 ( 22.0 )
    2779.364 ( 21.4 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented
    Comparison groups
    AMB dispersed in water v Reference AMB
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of adjusted geometric mean
    Point estimate
    1.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.08
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented
    Comparison groups
    AMB oral tablet v Reference AMB
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of adjusted geometric mean
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.07

    Primary: Apparent terminal phase half-life (t1/2) after administration of AMB under fasted condition

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    End point title
    		 Apparent terminal phase half-life (t1/2) after administration of AMB under fasted condition [15]
    End point description
    Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified data points were analysed.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this endpoint.
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    23
    19
    22
    Units: Hour
        geometric mean (geometric coefficient of variation)
    19.250 ( 15.6 )
    18.119 ( 19.3 )
    18.197 ( 16.4 )
    No statistical analyses for this end point

    Secondary: Number of participants with Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=2%)

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    End point title
    		 Number of participants with Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=2%)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment were categorized as SAE. Safety Population comprises of all randomized participants who took at least 1 dose of study intervention. Participants were analyzed according to the intervention actually received. Only those participants with data available at the specified data points were analysed.
    End point type
    Secondary
    End point timeframe
    Up to 40 days
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [16]
    25
    26
    Units: Participants
        non-SAE (>=2%)
    5
    7
    5
        SAE
    0
    0
    0
    Notes
    [16] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

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    End point title
    		 Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
    End point description
    Vital signs were measured in semi-supine position after 5 minutes rest and included Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Heart rate (HR). Data for number of participants with Post-Baseline worst case Vital Sign results relative to PCI Criteria relative to Baseline has been presented. Participants are counted in worst case category that their value changes to low, within range or high. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in "Within Range or No Change" category. Participants with missing baseline value are assumed as within range value. PCI ranges were: SBP [lower: <85, upper: >160 millimeter of mercury (mmHg)]; DBP (lower: <40, upper: >110 mmHg); HR (lower: <45, upper: >100 beats per minute). The value at Day 1 was considered as Baseline. Only those participants with data available at the specified data points were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to 40 days
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [17]
    25
    26
    Units: Participants
        SBP, To Low
    0
    0
    0
        SBP, To High
    0
    0
    0
        DBP, To Low
    0
    0
    0
        DBP, To High
    0
    0
    0
        HR, To Low
    2
    0
    0
        HR, To High
    0
    0
    0
        SBP, Within Range or No Change
    27
    25
    26
        DBP, Within Range or No Change
    27
    25
    26
        HR, Within Range or No Change
    25
    25
    26
    Notes
    [17] - Safety Population.
    No statistical analyses for this end point

    Secondary: Number of participants with worst case post-Baseline abnormal Electrocardiogram (ECG) Findings

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    End point title
    		 Number of participants with worst case post-Baseline abnormal Electrocardiogram (ECG) Findings
    End point description
    12-lead ECGs were recorded in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal clinically significant ECG findings for worst case post-Baseline has been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. The value at Day 1 was considered as Baseline. Only those participants with data available at the specified data points were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to 40 days
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [18]
    25
    26
    Units: Participants
        Abnormal, not clinically significant
    5
    6
    5
        Abnormal - clinically significant
    0
    0
    0
    Notes
    [18] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with worst case hematology results relative to PCI criteria post-Baseline relative to Baseline

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    End point title
    		 Number of participants with worst case hematology results relative to PCI criteria post-Baseline relative to Baseline
    End point description
    Blood samples were collected to analyze hemoglobin, hematocrit, lymphocytes, total neutrophils, platelet count, and white blood cell(WBC) counts. PCI ranges were hematocrit (high: >0.54 proportion of red blood cells in blood and low: change from Baseline <0.075); hemoglobin(high: >180 grams per liter[g/L] and low: change from Baseline <25 g/L); lymphocytes (low: <0.8 Giga cells per liter[GI/L]); platelet count (low: <100 GI/L and high: >550 GI/L); neutrophil count (low: <1.5 GI/L); WBC count (low: <3 GI/L and high: >20 GI/L). Participants were counted in worst-case category that their value changed to low, within range or no change, or high unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in ''To within Range or No Change' category. Baseline is defined as Day -1. Participants with data available at specified data points were presented as n= X in category titles
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and up to 40 days
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [19]
    25
    26
    Units: Participants
        Hemoglobin, To Low, , n=27, 25, 26
    0
    0
    0
        Hemoglobin, To High, , n=27, 25, 26
    0
    0
    0
        Hematocrit, To Low, n=27, 25, 26
    0
    0
    0
        Hematocrit, To High, n=27, 25, 26
    0
    0
    0
        Lymphocytes, To Low, n=27, 25, 26
    0
    1
    0
        Lymphocytes, To High, n=27, 25, 26
    0
    0
    0
        Neutrophil , To Low, n=27, 25, 26
    1
    0
    1
        Neutrophil , To High, n=27, 25, 26
    0
    0
    0
        Platelet, To Low, n=27, 24, 26
    0
    0
    0
        Platelet, To High, n=27, 24, 26
    0
    0
    0
        WBC, To Low, n=27, 25, 26
    0
    0
    0
        WBC, To High, n=27, 25, 26
    0
    0
    0
        Hemoglobin,To within Range/No Change, n=27, 25,26
    27
    25
    26
        Hematocrit,To within Range/No Change, n=27, 25,26
    27
    25
    26
        Lymphocytes,To within Range/No Change,n=27,25,26
    27
    24
    26
        Neutrophil,To within Range/No Change, n=27,25,26
    26
    25
    25
        Platelet,To within Range/No Change,n=27,24,26
    27
    24
    26
        WBC,To within Range/No Change,n=27,25,26
    27
    25
    26
    Notes
    [19] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with worst case clinical chemistry results relative to PCI criteria post-Baseline relative to Baseline

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    End point title
    		 Number of participants with worst case clinical chemistry results relative to PCI criteria post-Baseline relative to Baseline
    End point description
    Blood samples were collected to analyze PCI ranges for aspartate amino transferase (AST), alanine amino transferase (ALT), & alkaline phosphatase (ALP) (high: >=2 times (*) upper limit of normal [ULN] International units per liter [IU/L]); total bilirubin (high: >=1.5 * ULN micromoles per liter [µmol/L]); calcium (low: <2 millimoles per liter [mmol/L] & high: >2.75 mmol/L); glucose (low: <3 & high: >9 mmol/L); potassium (low: <3 & high: >5.5 mmol/L); sodium (low: <130 & high: >150 mmol/L) & Blood Urea Nitrogen (BUN) (high: >=2 * ULN µmol/L). Participants were counted in worst-case category that their value changed to (low, within range or no change, or high) unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the 'To within Range or No Change' category. Participants with data available at specified data points were presented as n= X in category titles
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and up to 40 days
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    27 [20]
    25
    26
    Units: Participants
        ALP,To Low, n=27, 25, 26
    0
    0
    0
        ALP,To High, n=27, 25, 26
    0
    0
    0
        ALT,To Low, n=27, 25, 26
    0
    0
    0
        ALT,To High, n=27, 25, 26
    0
    0
    0
        AST,To Low, n=26, 25, 26
    0
    0
    0
        AST,To High, n=26, 25, 26
    0
    0
    0
        Bilirubin,To Low, n=27, 25, 26
    0
    0
    0
        Bilirubin,To High, n=27, 25, 26
    0
    0
    0
        Calcium,To Low, n=27, 25, 26
    0
    0
    0
        Calcium,To High, n=27, 25, 26
    0
    0
    0
        Glucose,To Low, n=27, 25, 26
    0
    0
    0
        Glucose,To High, n=27, 25, 26
    2
    1
    1
        Potassium,To Low, n=27, 25, 26
    0
    0
    0
        Potassium,To High, n=27, 25, 26
    0
    0
    0
        Sodium,To Low, n=27, 25, 26
    0
    0
    0
        Sodium,To High, n=27, 25, 26
    0
    0
    0
        BUN,To Low, n=27, 25, 26
    0
    0
    0
        BUN,To High, n=27, 25, 26
    0
    0
    0
        ALP,To within Range/No Change,n=27, 25, 26
    27
    25
    26
        ALT,To within Range/No Change, n=27, 25, 26
    27
    25
    26
        AST,To within Range/No Change, n=26, 25, 26
    26
    25
    26
        Bilirubin,To within Range/No Change, n=27, 25, 26
    27
    25
    26
        Calcium,To within Range/No Change, n=27, 25, 26
    27
    25
    26
        Glucose,To within Range/No Change, n=27, 25, 26
    25
    24
    25
        Potassium,To within Range/No Change, n=27, 25, 26
    27
    25
    26
        Sodium,To within Range/No Change, n=27, 25, 26
    27
    25
    26
        BUN,To within Range/No Change, n=27, 25, 26
    27
    25
    26
    Notes
    [20] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline

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    End point title
    		 Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
    End point description
    Urine samples were collected for analysis of cellular casts, granular casts, hyaline casts, red blood cells. WBCs were counted as cells per high-power field (cells/HPF). Participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented. Baseline is defined as Day -1. Only those participants with data available at the specified data points were analysed.
    End point type
    Secondary
    End point timeframe
    Up to 40 days
    End point values
    		 AMB dispersed in water AMB oral tablet Reference AMB
    Number of subjects analysed
    3 [21]
    1
    4
    Units: Participants
        Urine Microscopy - Cellular Casts
    0
    0
    0
        Urine Microscopy - Granular Casts
    0
    0
    0
        Urine Microscopy - Hyaline Casts
    0
    0
    0
        Urine Microscopy - Red Blood Cells
    0
    0
    0
        Urine Microscopy-WBCs (1-9 cells/HPF)
    1
    0
    1
    Notes
    [21] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs and non-SAEs were collected from the start of study treatment until the follow up (Up to 40 days)
    Adverse event reporting additional description
    SAEs and Non-SAEs were reported for Safety Population which comprised of all participants who received at least one dose of study intervention. Data is presented treatment wise.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    AMB dispersed in water
    Reporting group description
    		 Participants received a single dose of 5 mg AMB tablet dispersed in water and administered orally

    Reporting group title
    Reference AMB
    Reporting group description
    		 Participants received a single dose of reference 5 mg AMB tablet administered orally

    Reporting group title
    AMB oral tablet
    Reporting group description
    		 Participants received a single dose of 5 mg AMB tablet administered intact orally

    Serious adverse events
    		 AMB dispersed in water Reference AMB AMB oral tablet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 AMB dispersed in water Reference AMB AMB oral tablet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 27 (18.52%)
    5 / 26 (19.23%)
    7 / 25 (28.00%)
    Investigations
    Heart rate increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 26 (7.69%)
    1 / 25 (4.00%)
         occurrences all number
    4
    2
    2
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter site swelling
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Malaise
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    3 / 25 (12.00%)
         occurrences all number
    0
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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