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

Phase 1 Completed 72 enrolled Sanofi Bristol-Myers Squibb · collab

RandomizedCrossoverDouble-blindBasic science

Summary

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 omeprazole 80 mg/day compared to given alone in healthy male and female subjects Secondary Objective: * Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

Timeline

Start: 2009-02
Primary completion: 2009-05
Completion: 2009-05

Publications

Results Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011 Jan;89(1):65-74. doi: 10.1038/clpt.2010.219. Epub 2010 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clopidogrel	Small molecule	75 mg	Oral
Subject	Omeprazole	Other / unclassified	80 mg	Oral

Indications

No indication recorded.