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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
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.
Details
| Lead sponsor | Teva Pharmaceuticals USA |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2003-04 |
| Completion | 2003-04 |
Conditions
- Healthy
Interventions
- Glyburide/Metformin 5 mg/500 mg Tablets
- Glucovance® 5 mg/500 mg Tablets
Primary outcomes
- Cmax (Maximum Observed Concentration) - Glyburide — Blood samples collected over 36 hour period
Bioequivalence based on Cmax - AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide — Blood samples collected over 36 hour period
Bioequivalence based on AUC0-inf - AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide — Blood samples collected over 36 hour period
Bioequivalence based on AUC0-t - Cmax (Maximum Observed Concentration) - Metformin — Blood samples collected over 36 hour period
Bioequivalence based on Cmax - AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin — Blood samples collected over 36 hour period
Bioequivalence based on AUC0-inf - AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin — Blood samples collected over 36 hour period
Bioequivalence based on AUC0-t
Countries
Canada