Antiplatelet Agents Clopidogrel Platelet inhibition Platelet aggregation
Conditions
Interventions
Apolets®
(generic clopidogrel product) 75 mg once daily,
for 7 days,Plavix®
(original clopidogrel product) 75 mg once daily,
Experimental Drug,Active Comparator Drug
Clopidogrel bisulfate,Clopidogrel hydrogen sulfate
Sponsors
Khon Kaen University
Khon Kaen University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic effect Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose on day 7 The platelet inhibition effect of clopidogrel at the various times on day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profiles Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose Area Under the Concentration-Time Curve (AUC 0-24), Cmax, Tmax | — |
Contacts
Public ContactWichittra Tassaneeyakul
Khon Kaen university
Outcome results
None listed