Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

A Randomized, Placebo-controlled, Two-sequence, Two-period Crossover Study, to Investigate a Potential Food Effect on the Pharmacodynamic and Bioavailability of Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) in Healthy Male Subjects

Primary objective:

• Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects

Secondary objectives are to investigate the potential food effect on:

• ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel
• Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel

The total duration per subject is 8-9 weeks broken down as follows:

• Screening: 2 to 21 days before the first dosing
• Fed period: 7 days including 5 treatment days
• Washout: at least 14 days after last dosing
• Fasted period: 7 days including 5 treatment days
• End of study: 7 to 10 days after the last dosing

Inclusion Criteria:

Healthy male subjects:

• as determined by medical history, physical examination including vital signs and clinical laboratory tests
• with a body weight between 50kg and 95 kg and a Body Mass Index (BMI) between 18 and 30 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.