CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Generic clopidogrel product Apolets® +1 moredrug
Likely dose
Generic clopidogrel product Apolets® 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02010632
NCT02010632Phase 1Completed
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Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers

Khon Kaen University·interventional·Posted Dec 13, 2013·Updated May 4, 2015

In Brief

A Phase 1 clinical trial evaluating Generic clopidogrel product Apolets® and Original clopidogrel product Plavix® for Pharmacodynamics. Completed, enrolled 32 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacodynamics
CountriesThailand
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 13, 2013
Enrollment StartAug 1, 2013
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.6 years ago

Interventions

Generic clopidogrel product Apolets®drug

* 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

Original clopidogrel product Plavix®drug

* 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