Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting
Summary
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.
Timeline
- Start
- 2003-04
- Primary completion
- 2003-04
- Completion
- 2003-04
Outcome
Met primary endpoint
registry Test/Ref Ratio of LS Means x 100 96.41 (90% CI 88.43 to 105.10) NCT00836472 ↗
registry Test/Ref Ratio of LS Means x 100 98.78 (90% CI 95.14 to 102.57) NCT00836472 ↗
registry Test/Ref Ratio of LS Means x 100 98.52 (90% CI 94.44 to 102.78) NCT00836472 ↗
registry Test/Ref Ratio of LS Means x 100 94.08 (90% CI 89.60 to 98.77) NCT00836472 ↗
registry Test/Ref Ratio of LS Means x 100 96.33 (90% CI 92.60 to 100.21) NCT00836472 ↗
registry Test/Ref Ratio of LS Means x 100 96.01 (90% CI 92.18 to 100.00) NCT00836472 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glyburide | Small molecule | 5 mg | — |
| Subject | Metformin | Small molecule | 500 mg | — |
Indications
No indication recorded.