Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Part of paid clinical trials in Austin, Texas.

Sponsor
AstraZeneca
Study ID
NCT00842556
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 20 mg, Single Dose
  • Glimepiride — DRUG
    Tablets, Oral, 4 mg, Single Dose
  • Sitagliptin — DRUG
    Tablets, Oral, 100 mg, Single Dose

Study Details

To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)

Key Dates

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

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Active Comparator: Dapagliflozin
  • Active Comparator: Glimepiride
  • Active Comparator: Dapagliflozin + Glimepiride
  • Active Comparator: Sitagliptin
  • Active Comparator: Dapagliflozin + Sitagliptin

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 after dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ppd DevelopmentAustinTexas78744-

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