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    Clinical Trial Results:
    Relative Bioavailability Study Between 75 Mg Tablet And 75 Mg Solution Of Clopidogrel (SR25990C) After Single Oral Administration To Young Healthy Men. Open, Crossover, Randomized And Monocenter Study

    Summary
    EudraCT number
    		 2015-001245-89
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 May 2002

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    12 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BDR4580
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly, Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000049-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
    03 Nov 2002
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2002
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the bioavailabilty of clopidogrel administered as 75 mg Plavix® tablet to that of 75 mg of clopidogrel in drinkable solution, after single oral administration, in fasting state, in normal healthy subjects
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Mar 2002
    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
    France: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at a single centre in France. A total of 24 subjects were screened between 25 March 2002 and 17 April 2002.

    Pre-assignment
    Screening details
    		 All 24 screened subjects were randomized.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Clopidogrel 75 mg Solution
    Arm description
    		 Single dose of clopidogrel solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    SR25990C
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Clopidogrel solution 75 mg.

    Arm title
    		 Clopidogrel 75 mg Tablet
    Arm description
    		 Single dose of clopidogrel tablet.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    SR25990C
    Other name
    Plavix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Clopidogrel tablet 75 mg.

    Number of subjects in period 1
    		Clopidogrel 75 mg Solution Clopidogrel 75 mg Tablet
    Started
    24
    24
    Treated
    24
    24
    Completed
    24
    24

    Baseline characteristics

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

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26 ( 5.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Clopidogrel 75 mg Solution
    Reporting group description
    		 Single dose of clopidogrel solution.

    Reporting group title
    Clopidogrel 75 mg Tablet
    Reporting group description
    		 Single dose of clopidogrel tablet.

    Primary: Clopidogrel Metabolite (SR26334) Pharmacokinetics: AUC, AUClast, and Cmax

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    End point title
    		 Clopidogrel Metabolite (SR26334) Pharmacokinetics: AUC, AUClast, and Cmax
    End point description
    AUC was defined as area under the plasma concentration versus time curve extrapolated to infinity. AUClast was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (time corresponding to the last concentration above the limit of quantification). Cmax was defined as maximum plasma concentration observed. A validated liquid chromatography mass spectrometry method (LCMS/MS) was used to quantify SR26334 concentrations.
    End point type
    Primary
    End point timeframe
    t (0h-48h)
    End point values
    		 Clopidogrel 75 mg Solution Clopidogrel 75 mg Tablet
    Number of subjects analysed
    24
    24
    Units: Specified in each category
    arithmetic mean (standard deviation)
        AUC (ng.h/mL) (n= 24, 23)
    8185.86 ( 1713.36 )
    7918.95 ( 1327.54 )
        AUClast (ng.h/mL) (n= 24, 24)
    8061.33 ( 1700 )
    7723.35 ( 1356.37 )
        Cmax (ng/mL) (n= 24, 24)
    3252 ( 835 )
    2762 ( 599 )
    Attachments
    		 Mean±SD SR26334 plasma conc. (n=24) - Linear scale
    Statistical analysis title
    		 AUC - Ratio Estimate
    Statistical analysis description
    Actual number of subjects included in analysis were 24
    Comparison groups
    Clopidogrel 75 mg Solution v Clopidogrel 75 mg Tablet
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.07
    Statistical analysis title
    		 AUClast - Ratio Estimate
    Statistical analysis description
    Actual number of subjects included in analysis were 24.
    Comparison groups
    Clopidogrel 75 mg Solution v Clopidogrel 75 mg Tablet
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.07
    Statistical analysis title
    		 Cmax - Ratio Estimate
    Statistical analysis description
    Actual number of subjects included in analysis were 24.
    Comparison groups
    Clopidogrel 75 mg Solution v Clopidogrel 75 mg Tablet
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.3

    Primary: Clopidogrel Metabolite (SR26334) Pharmacokinetics: Tmax

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    End point title
    		 Clopidogrel Metabolite (SR26334) Pharmacokinetics: Tmax
    End point description
    tmax was defined as time to reach maximum plasma concentration (Cmax).
    End point type
    Primary
    End point timeframe
    t (0h-48h)
    End point values
    		 Clopidogrel 75 mg Solution Clopidogrel 75 mg Tablet
    Number of subjects analysed
    24
    24
    Units: Hours
        median (full range (min-max))
    0.5 (0.33 to 2)
    0.75 (0.5 to 1.5)
    Statistical analysis title
    		 tmax - Ratio Estimate
    Statistical analysis description
    Actual number of subjects included in analysis were 24.
    Comparison groups
    Clopidogrel 75 mg Solution v Clopidogrel 75 mg Tablet
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio estimate
    Point estimate
    -0.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 -0.09

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 24) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from study drug administration up to 24 hours post dose).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    5.1
    Reporting groups
    Reporting group title
    Clopidogrel Solution
    Reporting group description
    		 Single dose of clopidogrel solution.

    Reporting group title
    Clopidogrel Tablet
    Reporting group description
    		 Clopidogrel tablet 75 mg.

    Serious adverse events
    		 Clopidogrel Solution Clopidogrel Tablet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Clopidogrel Solution Clopidogrel Tablet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subject experienced any adverse event.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Apr 2002
    Change of the principal Investigator for administrative reasons.

    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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