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Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Pharmacodynamics Clinical Trial

Official title:
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers

Clinical Trial 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

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02010632
Study type Interventional
Source Khon Kaen University
Contact
Status Completed
Phase Phase 1
Start date August 2013
Completion date December 2014
View Details
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