Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

Primary objective: * Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects Secondary Objectives: * Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval

Key facts

Study ID: NCT01129388
Run by: Sanofi
People needed: 72
Starts: 2009-03-01
Expected to finish: 2009-05-01
Last updated by the study team: 2011-12-15

Who can join

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

You may qualify if…

Healthy subject,
as determined by medical history, physical examination including vital signs and clinical laboratory tests.
with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with 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
Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
Any contraindication to clopidogrel and/or omeprazole
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

Full record on ClinicalTrials.gov

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