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Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Information source: Khon Kaen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacodynamics

Intervention: Generic clopidogrel product Apolets® (Drug); Original clopidogrel product Plavix® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Khon Kaen University

Official(s) and/or principal investigator(s):
Wichittra Tassaneeyakul, Ph.D., Principal Investigator, Affiliation: Khon Kaen University
Somsak Tiamkao, MD, Principal Investigator, Affiliation: Khon Kaen University
Sirimas Kanjanawart, Ph.D., Principal Investigator, Affiliation: Khon Kaen University
Kutcharin Phunikhom, MD, Principal Investigator, Affiliation: Khon Kaen University
Nontaya Nakkam, B.Pharm, Principal Investigator, Affiliation: Khon Kaen University
Thanawat Kaewkamsorn, M.Sc., Principal Investigator, Affiliation: Khon Kaen University

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

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

Secondary outcome:

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

Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)

Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)

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).

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Faculty of Medicine, Khon Kaen University, Khonkaen, Khon Kaen 40000, Thailand
Additional Information

Starting date: August 2013
Last updated: April 16, 2015

Page last updated: August 23, 2015

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