Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Part of paid clinical trials in Neptune City, New Jersey.

Sponsor
AstraZeneca
Study ID
NCT00839683
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • simvastatin — DRUG
    Tablets, Oral, 20 mg, Single Dose
  • Dapagliflozin — DRUG
    Tablets, Oral, 20 mg, Single Dose
  • simvastatin — DRUG
    Oral, 40 mg, Single Dose
  • valsartan — DRUG
    Tablets, Oral, 320 mg, Single Dose

Study Details

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

Key Dates

Start date
Feb 28, 2009
Status verified
Oct 2016
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Active Comparator: simvastatin
  • Active Comparator: Dapagliflozin + simvastatin
  • Active Comparator: Dapagliflozin
  • Active Comparator: valsartan
  • Active Comparator: Dapagliflozin + valsartan

Primary Outcome Measure

Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs [ Time Frame: 72 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mds Pharma Services (Us) Inc.Neptune CityNew Jersey07753-

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