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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00835991 |
The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Glyburide/Metformin 5 mg/500 mg Tablets Drug: Glucovance® 5 mg/500 mg Tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Randomized, 2-Way Crossover, Bioequivalence Study of Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets and Glucovance® 5 mg/500 mg Film-Coated Tablets in Healthy Subjects Under Fed Conditions |
Enrollment: | 60 |
Study Start Date: | February 2003 |
Study Completion Date: | February 2003 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Glyburide/Metformin 5 mg/500 mg Tablets
1 x 5 mg/500 mg, single-dose fed
|
2: Active Comparator |
Drug: Glucovance® 5 mg/500 mg Tablets
1 x 5 mg/500 mg, single-dose fed
|
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:
Female subjects of childbearing potential who have had unprotected sexual intercourse with any non-steril male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. The acceptable methods of contraception are:
Study ID Numbers: | 02350 |
Study First Received: | February 3, 2009 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00835991 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Bioequivalence Healthy Subjects |
Glyburide Hypoglycemic Agents Malnutrition Metformin Healthy |
Glyburide Hypoglycemic Agents Physiological Effects of Drugs Metformin Pharmacologic Actions |