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    Clinical Trial Results:
    An open-label, randomized, single dose, two period, crossover study to determine the bioequivalence between valsartan 160 mg pediatric final market image (FMI) formulation (solution) and clinical service form (CSF) of valsartan 160 mg extemporaneous suspension in healthy adult volunteers.

    Summary
    EudraCT number
    		 2016-004323-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Aug 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2018
    First version publication date
    28 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVAL489K2101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000005-PIP01-07
    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 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the rate and extent of absorption of valsartan between the valsartan pediatric FMI formulation and a valsartan CSF extemporaneous suspension.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2008
    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
    India: 86
    Worldwide total number of subjects
    86
    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)
    86
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Each subject participated in a 21-day screening period, two baseline periods and two treatment periods and an end-of-study evaluation. The washout period between the two treatments was at least 7 days.

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

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 Treatment sequence: Valsartan pediatric FMI formulation(3mg/mL)/Valsartan CSF extemporaneous suspension(16mg/mL) followed by Valsartan CSF extemporaneous suspension (16mg/mL)/ Valsartan pediatric FMI formulation (3mg/mL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A suspension was prepared by using marketed valsartan tablets 160 mg, commercially available suspending and sweetening agent. 53.3 ml of this solution will be administered, so that the final dose will be equivalent to 160 mg Valsartan.

    Investigational medicinal product name
    Ora-Plus®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    A commercial suspending vehicle.

    Investigational medicinal product name
    Ora-Sweet®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    A commercial sweetening vehicle.

    Investigational medicinal product name
    Valsartan Extemporaneous Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A suspension was prepared by using marketed valsartan tablets 160 mg, commercially available suspending and sweetening agent. 10 ml of this suspension was administered orally to give 160 mg Valsartan.

    Number of subjects in period 1
    		All Subjects
    Started
    86
    Completed
    81
    Not completed
    5
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    2
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 86 86
    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)
    		 86 86
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.8 ± 6.27 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 86 86

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Treatment sequence: Valsartan pediatric FMI formulation(3mg/mL)/Valsartan CSF extemporaneous suspension(16mg/mL) followed by Valsartan CSF extemporaneous suspension (16mg/mL)/ Valsartan pediatric FMI formulation (3mg/mL).

    Subject analysis set title
    Treatment A - Solution formulation
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Valsartan pediatric FMI formulation (3 mg/mL oral solution)

    Subject analysis set title
    Treatment B - Extemporaneous suspension
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Valsartan CSF extemporaneous suspension (16 mg/mL oral suspension)

    Primary: Cmax of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg valsartan CSF extemporaneous suspension

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    End point title
    		 Cmax of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg valsartan CSF extemporaneous suspension
    End point description
    Maximum (peak) plasma (or blood, serum, other body fluid) drug concentration after drug administration [ng/mL]
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 2 , 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post - dosing following Treatment A and Treatment B.
    End point values
    		 Treatment A - Solution formulation Treatment B - Extemporaneous suspension
    Number of subjects analysed
    83 [1]
    83 [2]
    Units: ng/mL
        arithmetic mean (standard deviation)
    8655 ± 1743
    6571 ± 1519
    Notes
    [1] - Pharmacokinetic Analysis Population
    [2] - Pharmacokinetic Analysis Population
    Statistical analysis title
    		 Geometric mean ratio of Cmax
    Comparison groups
    Treatment A - Solution formulation v Treatment B - Extemporaneous suspension
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.32
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 1.38

    Primary: AUC (0-t) and AUC (0-∞ ) of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg Valsartan CSF extemporaneous suspension

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    End point title
    		 AUC (0-t) and AUC (0-∞ ) of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg Valsartan CSF extemporaneous suspension
    End point description
    AUC(0-t) measures area under the concentration-time curve from time zero to time t, where t is the last time point with measurable concentration [h.ng/mL]. AUC(0-∞ ) measures area under the concentration-time curve from time zero to infinity [h.ng/mL].
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 2 , 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post - dosing following Treatment A and Treatment B.
    End point values
    		 Treatment A - Solution formulation Treatment B - Extemporaneous suspension
    Number of subjects analysed
    82 [3]
    82 [4]
    Units: h.ng/mL
    arithmetic mean (standard deviation)
        AUC (0-t)
    52410 ± 14951
    48080 ± 14140
        AUC (0-∞ )
    52910 ± 15050
    48540 ± 14240
    Notes
    [3] - Pharmacokinetic Analysis Population
    [4] - Pharmacokinetic Analysis Population
    Statistical analysis title
    		 Geometric mean ratio of AUC (0-t)
    Comparison groups
    Treatment B - Extemporaneous suspension v Treatment A - Solution formulation
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.13
    Statistical analysis title
    		 Geometric mean ratio of AUC (0-∞ )
    Comparison groups
    Treatment A - Solution formulation v Treatment B - Extemporaneous suspension
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.13

    Primary: Tmax of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg Valsartan CSF extemporaneous suspension

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    End point title
    		 Tmax of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg Valsartan CSF extemporaneous suspension [5]
    End point description
    Tmax measures time to reach peak or maximum concentration following drug administration [h].
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 2 , 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post - dosing following Treatment A and Treatment B.
    Notes
    [5] - 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 have been reported for this primary end point.
    End point values
    		 Treatment A - Solution formulation Treatment B - Extemporaneous suspension
    Number of subjects analysed
    83 [6]
    83 [7]
    Units: hour
        median (full range (min-max))
    1.0 (1.0 to 2.0)
    3.0 (1.0 to 4.0)
    Notes
    [6] - Pharmacokinetic Analysis Population
    [7] - Pharmacokinetic Analysis Population
    No statistical analyses for this end point

    Primary: T1/2 of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg Valsartan CSF extemporaneous suspension

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    End point title
    		 T1/2 of Valsartan following single oral dose of 160 mg Valsartan pediatric FMI solution formulation and 160 mg Valsartan CSF extemporaneous suspension [8]
    End point description
    t1/2 The elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve [h]
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 2 , 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post - dosing following Treatment A and Treatment B.
    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 have been reported for this primary end point.
    End point values
    		 Treatment A - Solution formulation Treatment B - Extemporaneous suspension
    Number of subjects analysed
    82 [9]
    82 [10]
    Units: hour
        arithmetic mean (standard deviation)
    7.6 ± 1.3
    7.6 ± 1.6
    Notes
    [9] - Pharmacokinetic Analysis Population
    [10] - Pharmacokinetic Analysis Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Valsartan pediatric FMI formulation (3mg/mL)
    Reporting group description
    		 Valsartan pediatric FMI formulation (3mg/mL)

    Reporting group title
    Valsartan CSF extemporaneous suspension (16mg/mL)
    Reporting group description
    		 Valsartan CSF extemporaneous suspension (16mg/mL)

    Reporting group title
    All Subjects
    Reporting group description
    		 All Subjects

    Serious adverse events
    		 Valsartan pediatric FMI formulation (3mg/mL) Valsartan CSF extemporaneous suspension (16mg/mL) All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 83 (0.00%)
    0 / 86 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Valsartan pediatric FMI formulation (3mg/mL) Valsartan CSF extemporaneous suspension (16mg/mL) All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 85 (4.71%)
    1 / 83 (1.20%)
    5 / 86 (5.81%)
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 83 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Gastrointestinal disorders
    VOMITING
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 83 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    GASTROENTERITIS
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 83 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    PHARYNGITIS
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 83 (1.20%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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