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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834743 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Glucophage® XR 750 mg Tablets Drug: Metformin ER 750 mg Tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | 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 |
Enrollment: | 32 |
Study Start Date: | August 2003 |
Study Completion Date: | August 2003 |
Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Metformin ER 750 mg Tablets
1 x 750 mg, single-dose fasting
|
2: Active Comparator |
Drug: Glucophage® XR 750 mg Tablets
1 x 750 mg, single-dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2734 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00834743 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Bioequivalence Healthy Subjects |
Hypoglycemic Agents Metformin Healthy |
Hypoglycemic Agents Physiological Effects of Drugs Metformin Pharmacologic Actions |