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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes

Treatments: Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb; Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882882

B013701

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 19 to 49 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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16 participants in 4 patient groups

1

Experimental group

Description:

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Treatment:

Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

2

Experimental group

Description:

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Treatment:

Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

3

Active Comparator group

Description:

GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Treatment:

Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

4

Active Comparator group

Description:

GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Treatment:

Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb