Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Khon Kaen University
• Treatments: Clopidogrel; Ticlopidine

Criteria

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.