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Trial record 15 of 1050 for:    clopidogrel

Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

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ClinicalTrials.gov Identifier: NCT02010632
Recruitment Status : Completed
First Posted : December 13, 2013
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Wichittra Tassaneeyakul, 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

Condition or disease Intervention/treatment Phase
Pharmacodynamics Drug: Generic clopidogrel product Apolets® Drug: Original clopidogrel product Plavix® Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010632


Locations
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Thailand
Faculty of Medicine, Khon Kaen University
Khonkaen, Khon Kaen, Thailand, 40000
Sponsors and Collaborators
Khon Kaen University
Investigators
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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

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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
First Posted: December 13, 2013    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by Wichittra Tassaneeyakul, Khon Kaen University:
Clopidogrel
Platelet inhibition
Platelet aggregation
Additional relevant MeSH terms:
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Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs