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

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

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

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

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.