To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Type II Diabetes
• Interventions: Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC; Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

• Registration Number: NCT00882882
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2001-06
• Study Completion: 2001-06
• Status Verified: 2009-04
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC	Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
2	Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC	Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
4	GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb	GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
3	GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb	GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	23 days