Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Phase 1

Completed

• Conditions: Pharmacodynamics
• Interventions: Drug: Original clopidogrel product Plavix®; Drug: Generic clopidogrel product Apolets®

• Registration Number: NCT02010632
• Lead Sponsor: Khon Kaen University

Brief 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

Detailed Description

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).

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-13
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Results First Submitted: 2015-03-30
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-16
• Last Update Submitted: 2015-04-16
• Results First Posted: 2015-05-04
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Original clopidogrel product	Original clopidogrel product Plavix®	Plavix® 75mg tablet
Generic clopidogrel product	Generic clopidogrel product Apolets®	Apolets® 75 mg tablet

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khonkaen, Khon Kaen, Thailand