Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Khon Kaen University

Status and phase

Completed

Phase 1

Conditions

Pharmacodynamics

Treatments

Drug: Original clopidogrel product Plavix®

Drug: Generic clopidogrel product Apolets®

Study type

Interventional

Funder types

Other

Identifiers

NCT02010632

PDPK-CLO-2013

Details and patient eligibility

About

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

Full 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).

Enrollment

32 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age between 18 and 45 years
Body mass index between 18-25 kg/m2
No clinically significant abnormalities, as confirmed on medical history; detailed physical examination; clinical laboratory analysis (blood hematology, biochemistry, prothrombin time, bleeding time, and urinalysis)

Exclusion criteria

An allergy to any drug; and/or a history of drug and/or alcohol abuse.
Subjects who had donated blood within 3 months prior to the start of this study or had participated in another investigational drug study within 3 months prior to the start of this study
Participating subjects were instructed to abstain from the use of any drugs for at least 2 weeks before and throughout the study.