Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacodynamics
• Intervention / Treatment: Drug: Generic clopidogrel product Apolets®; Drug: Original clopidogrel product 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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen
    • Khonkaen, Khon Kaen, Thailand, 40000
      • Faculty of Medicine, Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Plavix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)	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

Outcome Measure	Time Frame
Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)	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
Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)	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
Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): May 4, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Clopidogrel; Platelet aggregation; Platelet inhibition
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: PDPK-CLO-2013