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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01129271

Run by

Sanofi

People needed

72

Starts

2009-04-01

Expected to finish

2009-06-01

Last updated by the study team

2011-12-15

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Paris, France

Full record on ClinicalTrials.gov

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