MedTrace Logo

Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg

NCT00650169 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Clopidogrel Bisulfate Tablets 75 mg

75mg, single dose fed

DRUG

Plavix® Tablets 75 mg

75mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Dorian Williams, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00650169 on ClinicalTrials.gov