Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
AstraZeneca
Study ID
NCT00904176
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 20 mg, followed by 10 mg, Single Dose
  • Warfarin — DRUG
    Tablets, Oral, 25 mg, Single Dose
  • Digoxin — DRUG
    Tablets, Oral, 0.25, Single Dose

Study Details

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.

Key Dates

First listed
May 19, 2009
Start date
Jun 30, 2009
Status verified
Oct 2016
Primary completion
Aug 31, 2009
Completion
Aug 31, 2009

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin + Warfarin
  • Active Comparator: Warfarin
  • Active Comparator: Dapagliflozin + Digoxin
  • Active Comparator: Digoxin

Primary Outcome Measure

Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs [ Time Frame: 216 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pra InternationalLenexaKansas66219-

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