| Trial ID: | L6440 |
| Source ID: | NCT00839683
|
| Associated Drug: |
Simvastatin
|
| Title: |
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: simvastatin|DRUG: Dapagliflozin|DRUG: simvastatin|DRUG: valsartan
|
| Outcome Measures: |
Primary: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs, 72 hours post-dose | Secondary: To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects, 15 timepoints|To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects, 15 timepoints|To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects, 15 timepoints
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2009-02
|
| Completion Date: |
2009-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-17
|
| Locations: |
Mds Pharma Services (Us) Inc., Neptune, New Jersey, 07753, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00839683
|
