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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649454 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Glipizide and Metformin HCl Tablets 5 mg/500 mg Drug: Metaglip® Tablets 5 mg/500 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Glipizide and Metformin HCl Tablets (5 mg/500 mg; Mylan) to Metaglip® Tablets (5 mg/500 mg; Bristol-Myers Squibb) in Healthy Volunteers |
| Enrollment: | 36 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Glipizide and Metformin HCl Tablets 5 mg/500 mg
|
Drug: Glipizide and Metformin HCl Tablets 5 mg/500 mg
5/500mg, single dose fasting
|
|
2: Active Comparator
Metaglip® Tablets 5 mg/500 mg
|
Drug: Metaglip® Tablets 5 mg/500 mg
5/500mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | MEGL-0493 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649454 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hypoglycemic Agents Glipizide Physiological Effects of Drugs Metformin Pharmacologic Actions |