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™), metformin (Glucophage™), metformin (Diabex)

Sex

All

Actual enrollment

28

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

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra-Zeneca

Inclusion and exclusion criteria