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
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
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No locations available
| 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™ |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
