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| Sponsor: | Teva Pharmaceuticals USA |
|---|---|
| Information provided by: | Teva Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT00836472 |
Purpose
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 fasting 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: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 Fasting Conditions |
| Enrollment: | 60 |
| Study Start Date: | April 2003 |
| Study Completion Date: | April 2003 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Glyburide Metformin
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
|
Drug: Glyburide/Metformin 5 mg/500 mg Tablets
1 x 5 mg/500 mg, single-dose fasting
|
|
Active Comparator: Glucovance®
Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
|
Drug: Glucovance® 5 mg/500 mg Tablets
1 x 5 mg/500 mg, single-dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Eligibility| 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:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00836472 History of Changes |
| Other Study ID Numbers: | 02349 |
| Study First Received: | February 3, 2009 |
| Results First Received: | June 30, 2009 |
| Last Updated: | September 1, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
|
Bioequivalence Healthy Subjects |
|
Glyburide Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |