MedTrace Logo

Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects

NCT01068730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-05-08

Study results available
· View outcomes & findings →

Summary

To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state

Conditions

Interventions

DRUG

metformin (Diabex)

Tablets, Oral, 500 mg, Once daily, single dose

DRUG

metformin (Glucophage™)

Tablets, Oral, 500 mg, Once Daily, single dose

DRUG

metformin (Glucophage™)

Tablets, Oral, 1000 mg, Once daily, single dose

DRUG

metformin (Diabex)

Tablets, Oral, 1000 mg, Once daily, single dose

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT01068730 on ClinicalTrials.gov