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Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fed Conditions

NCT00778466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2008-10-23

No results posted yet for this study

Summary

The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fed conditions in healthy, male and female adult subjects.

Conditions

  • Healthy

Interventions

DRUG

metformin hydrochloride 1000 mg tablets

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-03-31
Completion
2006-04-30

Countries

  • United States

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 NCT00778466 on ClinicalTrials.gov