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Completed

NCT Number: NCT02010632

Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

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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Key information

Conditions

Pharmacodynamics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Medicine, Khon Kaen University

Khonkaen, Changwat Khon Kaen, 40000, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Apolets®

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

Other names: Plavix®

Primary outcomes

  1. Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)

    Time frame: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Secondary outcomes

  1. Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)

    Time frame: 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

  2. Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)

    Time frame: 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

  3. Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2013
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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