Comparative pharmacodynamics and pharmacokinetics study of generic and reference clopidogrel products in Thai Healthy volunteers

Phase 1

Recruiting

• Conditions: Antiplatelet Agents; Clopidogrel; Platelet inhibition; Platelet aggregation

• Registration Number: TCTR20131204001
• Lead Sponsor: Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-04
• Study Completion: 2014-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic effect Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose on day 7 The platelet inhibition effect of clopidogrel at the various times on day 7

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profiles Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose Area Under the Concentration-Time Curve (AUC 0-24), Cmax, Tmax