Study identifier:MB102-058
ClinicalTrials.gov identifier:NCT00904176
EudraCT identifier:N/A
CTIS identifier:N/A
Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects
Type 2 Diabetes Mellitus
Phase 1
Yes
Dapagliflozin, Warfarin, Digoxin
All
30
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Oct 2016 by AstraZeneca
AstraZeneca
Bristol-Myers Squibb
The purpose of this study is determine that Dapagliflozin has no effect on the pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin when dapagliflozin is coadministered with digoxin.
Location
Location
Lenexa, KS, United States, 66219
Arms | Assigned Interventions |
---|---|
Active Comparator: Dapagliflozin + Warfarin | Drug: Dapagliflozin Tablets, Oral, 20 mg, followed by 10 mg, Single Dose Drug: Warfarin Tablets, Oral, 25 mg, Single Dose Other Name: Coumadin |
Active Comparator: Warfarin | Drug: Warfarin Tablets, Oral, 25 mg, Single Dose Other Name: Coumadin |
Active Comparator: Dapagliflozin + Digoxin | Drug: Dapagliflozin Tablets, Oral, 20 mg, followed by 10 mg, Single Dose Drug: Digoxin Tablets, Oral, 0.25, Single Dose Other Name: Lanoxin |
Active Comparator: Digoxin | Drug: Digoxin Tablets, Oral, 0.25, Single Dose Other Name: Lanoxin |
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