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Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition

NCT01053689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-01-21

No results posted yet for this study

Summary

The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed condition.

Conditions

  • Healthy

Interventions

DRUG

Glimepiride tablets 1 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, MD · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2003-12-31
Completion
2003-12-31

Countries

  • Canada

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 NCT01053689 on ClinicalTrials.gov