Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects

Study Overview
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Brief Summary
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The objectives of the study are to: Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

Detailed Description
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The total study duration per subject is 4 - 6 weeks broken down as follows: Screening: 2 to 21 days before the first dosing Period 1, 2 and 3: 4 days including 1 treatment day each Washout between periods: at least 7 days between 2 administrations End of study: 7 to 10 days after the last dosing

Official Title
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An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects: as determined by medical history and complete physical examination including vital signs and clinical laboratory tests with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 kg/m2 Exclusion Criteria: Evidence of inherited disorder of coagulation/hemostasis functions Smoking more than 5 cigarettes or equivalent per day Abnormal hemostasis screen Any contraindication to clopidogrel Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence clopidogrel 75 / 75 / 300 mg<br>Period 1: clopidogrel 75 mg single dose Period 2: clopidogrel 75 mg single dose Period 3: clopidogrel 300 mg single dose Each intake is at around 8:00 AM under fasted conditions. | Drug: Clopidogrel<br>* Pharmaceutical form : tablet Route of administration: oral<br>* Other names: SR25990;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC)) |  | Up to 48 hours postdose for each period | 
| Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC) |  | Up to 48 hours postdose for each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z)) |  | Up to 48 hours postdose for each period | 
| Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z) |  | Up to 48 hours postdose for each period |