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

ClinicalTrials.gov ID: NCT01068730

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Official title

Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets Manufactured by Bristol-Myers Squibb Relative to 500 mg and 1000 mg Diabex (Metformin) Tablets Marketed in Australia by Alphapharm Administered to Healthy Subjects in the Fed State

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT01068730
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: AstraZeneca; Industry
Enrollment: 28 participants

Conditions and interventions

Conditions

Type 2 Diabetes Mellitus

Interventions

metformin (Diabex) Drug
metformin (Glucophage™) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 2010 (Type not available)
Primary completion: Apr 2010 (Actual)
Completion: Apr 2010 (Actual)
Last update posted: May 8, 2015

2010

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
PPD Development, LP	Austin	Texas	78744	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01068730, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 8, 2015 · Synced Nov 12, 2026