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

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

Timeline

Start

2009-04

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

paper with the 90% CI (0.9%-8.5%) contained within the prespecified equipotency range of ±15%. PMID 22128201 ↗

paper These findings confirm that clopidogrel can be taken with or without food. PMID 22128201 ↗

Publications

• Results Hurbin F, Boulenc X, Daskalakis N, Farenc C, Taylor T, Bonneau D, Lacreta F, Cheng S, Sultan E. Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men. J Clin Pharmacol. 2012 Oct;52(10):1506-15. doi: 10.1177/0091270011419852. Epub 2011 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clopidogrel	Small molecule	75 mg	Oral

Indications

No indication recorded.