| Trial ID: | L2046 |
| Source ID: | NCT00904176
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Warfarin|DRUG: Digoxin
|
| Outcome Measures: |
Primary: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs, 216 hours post-dose | Secondary: To assess the effect of dapagliflozin on the PK of R-warfarin, when warfarin and dapagliflozin are coadministered in healthy subjects (Cohort 1), 16 time points|To assess the safety and tolerability of the combination of dapagliflozin with warfarin, and the combination of dapagliflozin with digoxin in healthy subjects, 16 time points
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-06
|
| Completion Date: |
2009-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-17
|
| Locations: |
Pra International, Lenexa, Kansas, 66219, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00904176
|
