NCT00834743

Metformin ER 750 mg Tablets, Fasting

A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Metformin ER 750 mg Tablets Versus Glucophage® XR 750 mg Tablets in Normal Healthy Non-smoking Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glucophage® XR 750 mg Tablets	1 x 750 mg, single-dose fasting
DRUG	Metformin ER 750 mg Tablets	1 x 750 mg, single-dose fasting

Timeline

• Start date: 2003-08-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada