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Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed Conditions

NCT01621763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-06-25

No results posted yet for this study

Summary

To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fed conditions and to assess the bioequivalence.

Conditions

  • Healthy

Interventions

DRUG

Clopidogrel

Clopidogrel Tablets 300 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Dimple Shah, MD · Lambda Therapeutic Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • India

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 NCT01621763 on ClinicalTrials.gov