Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Study Overview
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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

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).

Official Title
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Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers

Conditions
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Pharmacodynamics

Intervention / Treatment
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* Drug: Generic clopidogrel product Apolets®
* Drug: Original clopidogrel product Plavix®


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Generic clopidogrel product<br>Apolets® 75 mg tablet | Drug: Generic clopidogrel product Apolets®<br>* 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<br>* Other names: Apolets®;|
| Active Comparator: Original clopidogrel product<br>Plavix® 75mg tablet | Drug: Original clopidogrel product Plavix®<br>* 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<br>* Other names: Plavix®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) |  | Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24) |  | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | 
| Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax) |  | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | 
| Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax) |  | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, Platelet inhibition, Platelet aggregation