5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-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 non-fasting conditions.
Timeline
- Start
- 2004-06
- Primary completion
- 2004-06
- Completion
- 2004-06
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Glipizide Metformin vs Metaglip™; Test/Ref Ratio of LS Means x 100 99.1 (90% CI 92.4 to 106.2) NCT00834587 ↗
registry analysis (non-inferiority or equivalence test); Glipizide Metformin vs Metaglip™; Test/Ref Ratio of LS Means x 100 100.7 (90% CI 98.8 to 102.6) NCT00834587 ↗
registry analysis (non-inferiority or equivalence test); Glipizide Metformin vs Metaglip™; Test/Ref Ratio of LS Means x 100 100.6 (90% CI 98.8 to 102.5) NCT00834587 ↗
registry analysis (non-inferiority or equivalence test); Glipizide Metformin vs Metaglip™; Test/Ref Ratio of LS Means x 100 101.7 (90% CI 97.3 to 106.3) NCT00834587 ↗
registry analysis (non-inferiority or equivalence test); Glipizide Metformin vs Metaglip™; Test/Ref Ratio of LS Means x 100 99.2 (90% CI 96.5 to 102.0) NCT00834587 ↗
registry analysis (non-inferiority or equivalence test); Glipizide Metformin vs Metaglip™; Test/Ref Ratio of LS Means x 100 99.1 (90% CI 96.5 to 101.8) NCT00834587 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glipizide | Small molecule | 5 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
Indications
No indication recorded.