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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-05-31

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

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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

Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence clopidogrel 75 / 75 / 300 mg

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.

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Pharmaceutical form : tablet

Route of administration: oral

Interventions

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Clopidogrel

Pharmaceutical form : tablet

Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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SR25990

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes