drugset / Trial / NCT03216278
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
RandomizedCrossoverOpen-labelTreatment
Summary
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
Timeline
- Start
- 2017-09-26
- Primary completion
- 2018-05-22
- Completion
- 2018-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dapagliflozin | Small molecule | 5 mg | Oral |
| Comparator | Dapagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Metformin | Small molecule | 500 mg | Oral |
| Comparator | Metformin | Small molecule | 1000 mg | Oral |
Indications
No indication recorded.