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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Clopidogrel; Ticlopidine

Criteria

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.