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Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Khon Kaen University
Sponsor:
Information provided by (Responsible Party):
Wichittra Tassaneeyakul, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT02010632
First received: December 3, 2013
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Antiplatelet Agents
Drug: Generic clopidogrel product Apolets®
Drug: Original clopidogrel product Plavix®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Generic clopidogrel product
Apolets® 75 mg tablet
Drug: Generic clopidogrel product Apolets®
  • 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 Name: Apolets®
Active Comparator: Original clopidogrel product
Plavix® 75mg tablet
Drug: Original clopidogrel product Plavix®
  • 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 Name: Plavix®

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010632

Contacts
Contact: Wichittra Tassaneeyakul, Ph.D. +66-43-348397 wichitt@kku.ac.th
Contact: Somsak Tiamkao, MD +66-43-363-665 somtia@kku.ac.th

Locations
Thailand
Faculty of Medicine, Khon Kaen University Recruiting
Khonkaen, Khon Kaen, Thailand, 40000
Contact: Wichittra Tassaneeyakul, Ph.D.    6643348397    wichitt@kku.ac.th   
Contact: Nontaya Nakkam, B.Pharm    66862642540    nonna_na@hotmail.com   
Principal Investigator: Wichittra Tassaneeyakul, Ph.D.         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Wichittra Tassaneeyakul, Ph.D. Khon Kaen University
Principal Investigator: Somsak Tiamkao, MD Khon Kaen University
Principal Investigator: Sirimas Kanjanawart, Ph.D. Khon Kaen University
Principal Investigator: Kutcharin Phunikhom, MD Khon Kaen University
Principal Investigator: Nontaya Nakkam, B.Pharm Khon Kaen University
Principal Investigator: Thanawat Kaewkamsorn, M.Sc. Khon Kaen University
  More Information

No publications provided

Responsible Party: Wichittra Tassaneeyakul, Professor Dr. Wichittra Tassaneeyakul, Departments of Pharmacology, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02010632     History of Changes
Other Study ID Numbers: PDPK-CLO-2013
Study First Received: December 3, 2013
Last Updated: September 22, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Clopidogrel
Platelet inhibition
Platelet aggregation

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014