Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects

Part of paid clinical trials in Austin, Texas.

Sponsor
AstraZeneca
Study ID
NCT00930865
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Bumetanide — DRUG
    Tablets, Oral, 1 mg, Single Dose, 7 Days
  • Dapagliflozin — DRUG
    Tablets, Oral, 10 mg. Single Dose, 7 Days

Study Details

To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects

Key Dates

Start date
Jul 31, 2009
Status verified
Oct 2016
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bumetanide
  • Active Comparator: Dapagliflozin
  • Active Comparator: Bumetanide + Dapagliflozin

Primary Outcome Measure

Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs [ Time Frame: 24 hours post-dose on Day 8 and 15 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ppd Development, LpAustinTexas78744-

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