Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Generic clopidogrel product

Apolets® 75 mg tablet

Group Type EXPERIMENTAL

Generic clopidogrel product Apolets®

Intervention Type 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® 75mg tablet

Group Type ACTIVE_COMPARATOR

Original clopidogrel product Plavix®

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Apolets® Plavix®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes