A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin HCL Tablets, 1000 mg Sandoz; Drug: Glucophage 1000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00865033

B053709

Details and patient eligibility

About

The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

Experimental group

Description:

Metformin HCL Tablets, 1000 mg

Treatment:

Drug: Metformin HCL Tablets, 1000 mg Sandoz

2

Active Comparator group

Description:

Glucophage 1000 mg Tablets

Treatment:

Drug: Glucophage 1000 mg