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

Sandoz32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Metformin HCL Tablets, 1000 mg SandozDRUG

Glucophage 1000 mgDRUG

Eligibility

Sex: ALLMin age: 18 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 according to US FDA guidelines

Time frame: 9 days

Data from ClinicalTrials.gov

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