Phase 1
Completed N=32
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
Pharmacodynamics
Source: ClinicalTrials.gov NCT02010632 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) — 1853.58; 1892.84 percent inhibition*hour
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) |
1853.58; 1892.84 | — |
| SECONDARY Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24) |
— | — |
| SECONDARY Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax) |
— | — |
| SECONDARY Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax) |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02010632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.