5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.
Timeline
- Start
- 2004-06
- Primary completion
- 2004-06
- Completion
- 2004-06
Outcome
Met primary endpoint
registry Test/Ref Ratio of LS Means x 100 86.5 (90% CI 81.8 to 91.6) NCT00835497 ↗
registry Test/Ref Ratio of LS Means x 100 97.0 (90% CI 94.2 to 99.9) NCT00835497 ↗
registry Test/Ref Ratio of LS Means x 100 97.0 (90% CI 94.2 to 99.8) NCT00835497 ↗
registry Test/Ref Ratio of LS Means x 100 88.9 (90% CI 83.5 to 94.6) NCT00835497 ↗
registry Test/Ref Ratio of LS Means x 100 92.7 (90% CI 88.4 to 97.1) NCT00835497 ↗
registry Test/Ref Ratio of LS Means x 100 93.0 (90% CI 88.8 to 97.5) NCT00835497 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glipizide | Small molecule | 5 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
Indications
No indication recorded.