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Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

NCT02010632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-05-04

Study results available
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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

Conditions

  • Pharmacodynamics

Interventions

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

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Wichittra Tassaneeyakul, Ph.D. · Khon Kaen University

  • Somsak Tiamkao, MD · Khon Kaen University

  • Sirimas Kanjanawart, Ph.D. · Khon Kaen University

  • Kutcharin Phunikhom, MD · Khon Kaen University

  • Nontaya Nakkam, B.Pharm · Khon Kaen University

  • Thanawat Kaewkamsorn, M.Sc. · Khon Kaen University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010632 on ClinicalTrials.gov