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

Phase 1CompletedNCT00882882

Sandoz16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type II Diabetes

Interventions

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTCDRUG

GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers SquibbDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 23 days

Data from ClinicalTrials.gov

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