Clinical trial NCT02010632: Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
Official title: Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacodynamics
Keywords: Clopidogrel
Platelet inhibition
Platelet aggregation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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 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.

Primary outcomes:
measure: Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
timeFrame: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
Secondary outcomes:
measure: Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)
timeFrame: 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
measure: Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)
timeFrame: 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
measure: Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)
timeFrame: 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
Other outcomes:
Locations:
city: Khonkaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: Wichittra Tassaneeyakul, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Somsak Tiamkao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Sirimas Kanjanawart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Kutcharin Phunikhom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Nontaya Nakkam, B.Pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Thanawat Kaewkamsorn, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: