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Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects

NCT01129063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-08-30

No results posted yet for this study

Summary

The objectives of the study are to:

* Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
* Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

Conditions

  • Healthy

Interventions

DRUG

Clopidogrel

Pharmaceutical form : tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • International Clinical Development Study Director · Sanofi

Study Design

Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • France

Study Locations

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Entities

Companies

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 NCT01129063 on ClinicalTrials.gov