Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in healthy subjects

Study identifier:CV181-120

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

metformin (Diabex), metformin (Glucophage™)

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Feb 2010

Primary Completion Date: 01 Apr 2010

Study Completion Date: 01 Apr 2010

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Astra-Zeneca

Inclusion and exclusion criteria

Location

PPD Development, LP

Austin, TX, United States, 78744

Arms	Assigned Interventions
Other: Treatment A 500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition	Drug: metformin (Diabex) Tablets, Oral, 500 mg, Once daily, single dose Other Name: Diabex
Other: Treatment B 500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition	Drug: metformin (Glucophage™) Tablets, Oral, 500 mg, Once Daily, single dose Other Name: Glucophage™
Other: Treatment C 1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition	Drug: metformin (Diabex) Tablets, Oral, 1000 mg, Once daily, single dose Other Name: Diabex
Other: Treatment D 1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition	Drug: metformin (Glucophage™) Tablets, Oral, 1000 mg, Once daily, single dose Other Name: Glucophage™

Documents available

BMS Clinical Trials Disclosure
Download
Investigator Inquiry form
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For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb