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