Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg 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 concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects * Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole Secondary Objective: * Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole
Key facts
- Study ID
- NCT01129427
- Run by
- Sanofi
- People needed
- 66
- Starts
- 2009-08-01
- Expected to finish
- 2009-11-01
- 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 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 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 pantoprazole
- 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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