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Comparative Bioavailability Study of Two Oral Formulations of Clopidogrel

NCT01447563 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-10-06

No results posted yet for this study

Summary

Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet activation, is widely used to prevent and reduce the risk of thrombotic events. Objective: the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75 mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral dose of the test or reference drug will be followed by a 7 day washout period, after which subjects will receive the alternative formulation. Blood samples were collected up to 24 h after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem mass spectrometry area under the plasma concentration time curve from zero to the last quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life (Tmax) and plasma half-life (T1/2) were calculated for both formulations.

Conditions

  • Comparative Bioavailability of Clopidogrel Tablets

Interventions

DRUG

Clopidogrel bisulfate

subjects received a single 75 mg tablet of the reference formulation, given with 250 mL water

DRUG

Clopidogrel

subjects received a single 75 mg tablet of the test formulation, given with 250 mL water

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Lourdes Garza Ocañas, MD PhD · Hospital Universitario Jose E Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-06-30
Completion
2008-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447563 on ClinicalTrials.gov