Conditions: Pharmacodynamics
Keywords: Clopidogrel Platelet inhibition Platelet aggregation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers

Detailed description:
Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).

Arms:
arm 1: Apolets® 75 mg tablet arm 2: Plavix® 75mg tablet

Interventions: intervention 1: Generic clopidogrel product Apolets® intervention 2: Original clopidogrel product Plavix®
Intervention descriptions: intervention 1: * Clopidogrel 75 mg once daily for 7 days
* Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 intervention 2: * Clopidogrel 75 mg once daily for 7 days
* Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Protocol document: