drugset / Trial / NCT00839683
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
RandomizedCrossoverOpen-label
Summary
Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects
Timeline
- Start
- 2009-02
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dapagliflozin | Small molecule | 20 mg | Oral |
| Comparator | Simvastatin | Small molecule | 20 mg | Oral |
| Comparator | Simvastatin | Small molecule | 40 mg | Oral |
| Comparator | Valsartan | Small molecule | 320 mg | Oral |