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Pharmacodynamics | Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Pharmacodynamics research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pharmacodynamics

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Generic clopidogrel product Apolets®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

Drug:Original clopidogrel product Plavix®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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Generic clopidogrel productApolets® 75 mg tablet

Original clopidogrel productPlavix® 75mg tablet

Study Status

Completed

Start Date: August 2013

Completed Date: December 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)

Secondary Outcome: Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)

Study sponsors, principal investigator, and references

Principal Investigator: Wichittra Tassaneeyakul, Ph.D.

Lead Sponsor: Khon Kaen University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02010632

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