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    Clinical Trial Results:
    A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Benicar®) in Healthy Adult Volunteers Under Fasting Conditions

    Summary
    EudraCT number
    		 2015-003005-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Dec 2004

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2018
    First version publication date
    02 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CS0866-A-U101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sankyo Pharma Development
    Sponsor organisation address
    399 Thornall Street, Edison, United States, NJ 08837
    Public contact
    Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, NJ 08837, United States, Jason Mann, +001 732 5905011, jamann@dsi.com
    Scientific contact
    Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, NJ 08837, United States, Jason Mann, +001 732 5905011, jamann@dsi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000897-PIP01-10
    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
    13 Dec 2004
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2004
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to determine if the compounded suspension formulation of olmesartan medoxomil (4 milligrams per milliliter [mg/mL] × 10 mL, for a total dose of 40 mg) is bioequivalent to the marketed tablet formulation of Benicar (1 × 40 mg tablet).
    Protection of trial subjects
    Safety variables included clinical and laboratory adverse events, concomitant medications, physical examination findings, vital signs, electrocardiogram (ECG) results, and hematology, serum chemistry, and urinalysis laboratory results.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2004
    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 States: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    0
    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)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were screened from 24 October 2004 to 14 November 2004.

    Pre-assignment
    Screening details
    		 A total of 26 subjects were enrolled and randomized into the study. Of these 24 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Sequence AB
    Arm description
    		 Subjects were administered with 10 milliliter (ml) (4 milligram per milliliter [mg/ml]) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 1 and 40 mg of olmesartan medoxomil tablet (Benicar) (Treatment B) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with olmesartan medoxomil oral suspension (Benicar 20 mg tablets dispersed in a vehicle containing water, Ora-Plus, and Ora-Sweet) on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Arm title
    		 Sequence BA
    Arm description
    		 Subjects were administered with 40 mg of olmesartan medoxomil tablet (Treatment B) on Day 1 of Period 1 and 10 mL (4 mg/mL) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with olmesartan medoxomil oral suspension (Benicar 20 mg tablets dispersed in a vehicle containing water, Ora-Plus, and Ora-Sweet) on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Number of subjects in period 1
    		Sequence AB Sequence BA
    Started
    13
    13
    Completed
    13
    11
    Not completed
    0
    2
         Physician decision
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence AB
    Reporting group description
    		 Subjects were administered with 10 milliliter (ml) (4 milligram per milliliter [mg/ml]) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 1 and 40 mg of olmesartan medoxomil tablet (Benicar) (Treatment B) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Reporting group title
    Sequence BA
    Reporting group description
    		 Subjects were administered with 40 mg of olmesartan medoxomil tablet (Treatment B) on Day 1 of Period 1 and 10 mL (4 mg/mL) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Reporting group values
    		 Sequence AB Sequence BA Total
    Number of subjects
    		 13 13 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 13 13 26
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2 4
        Male
    		 11 11 22

    End points

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    End points reporting groups
    Reporting group title
    Sequence AB
    Reporting group description
    		 Subjects were administered with 10 milliliter (ml) (4 milligram per milliliter [mg/ml]) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 1 and 40 mg of olmesartan medoxomil tablet (Benicar) (Treatment B) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Reporting group title
    Sequence BA
    Reporting group description
    		 Subjects were administered with 40 mg of olmesartan medoxomil tablet (Treatment B) on Day 1 of Period 1 and 10 mL (4 mg/mL) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Subject analysis set title
    Treatment A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects included who were received at least one dose of 10 mL (4 mg/mL) olmesartan medoxomil oral suspension on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Subject analysis set title
    Treatment B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects included who were received at least one dose of 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Primary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Olmesartan Medoxomil

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    End point title
    		 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Olmesartan Medoxomil
    End point description
    The AUC(0-t) is the area under the curve from time zero to last quantifiable concentration of olmesartan medoxomil. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    End point values
    		 Treatment A Treatment B
    Number of subjects analysed
    24
    26
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    6812.6 ( 24.3 )
    6358.5 ( 27 )
    Statistical analysis title
    		 Statistical Analysis: AUC0-t
    Statistical analysis description
    The statistical analyses were performed using the SAS® Mixed Procedure. There were a total of 26 subjects included in this analysis (cross-over design).
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric Means Ratio
    Point estimate
    105.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 97.7
         upper limit
    		 113.3

    Primary: Maximum Observed Plasma Concentration (Cmax) of Olmesartan Medoxomil

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Olmesartan Medoxomil
    End point description
    The Cmax is the maximum observed plasma concentration of olmesartan medoxomil. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    End point values
    		 Treatment A Treatment B
    Number of subjects analysed
    24
    26
    Units: nanogram /milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    1036.9 ( 27.3 )
    949.6 ( 27.9 )
    Statistical analysis title
    		 Statistical Analysis: Cmax
    Statistical analysis description
    The statistical analyses were performed using the SAS® Mixed Procedure. There were a total of 26 subjects included in this analysis (cross-over design).
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric Means Ratio
    Point estimate
    106.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 97.8
         upper limit
    		 116.3

    Primary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Olmesartan Medoxomil

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    End point title
    		 Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Olmesartan Medoxomil
    End point description
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile. Here 'number of subject analysed' is the number of subject analysed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    End point values
    		 Treatment A Treatment B
    Number of subjects analysed
    20
    23
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    7184.2 ( 26.6 )
    6594.3 ( 28 )
    Statistical analysis title
    		 Statistical Analysis: AUC0-inf
    Statistical analysis description
    The statistical analyses were performed using the SAS® Mixed Procedure. There were a total of 23 subjects included in this analysis (cross-over design).
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric Means Ratio
    Point estimate
    107.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 97.5
         upper limit
    		 117.9

    Primary: Ratio of AUC0-t to AUC0-inf (AUC0-t to AUCinf) of Olmesartan Medoxomil

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    End point title
    		 Ratio of AUC0-t to AUC0-inf (AUC0-t to AUCinf) of Olmesartan Medoxomil [1]
    End point description
    Ratio of AUC0-t to AUC0-inf (AUC0-t to AUCinf) of olmesartan medoxomil. Here number of subject analysed' is the number of subject analysed for this outcome measure. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    Notes
    [1] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Treatment A Treatment B
    Number of subjects analysed
    20
    23
    Units: Ratio
        arithmetic mean (standard deviation)
    0.9722 ( 0.03137 )
    0.9745 ( 0.0219 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of the study treatment up to Day 3 of Period 2 (approximately 11 days)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 Subjects included who were received at least one dose of 10 mL (4 mg/mL) olmesartan medoxomil oral suspension on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Reporting group title
    Treatment B
    Reporting group description
    		 Subjects included who were received at least one dose of 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Serious adverse events
    		 Treatment A Treatment B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment A Treatment B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 11 (18.18%)
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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