Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Sponsor
AstraZeneca
Study ID
NCT00562250
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 20 mg, once daily, single dose
  • Glimepiride — DRUG
    Tablets, Oral, 4 mg, once daily, single dose
  • Dapagliflozin + Glimepiride — DRUG
    Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Study Details

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Key Dates

Start date
May 31, 2008
Status verified
Oct 2016
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008

Study Design

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

Arms

  • Experimental: Arm 1
  • Active Comparator: Arm 2
  • Active Comparator: Arm 3

Primary Outcome Measure

Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together [ Time Frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose ]

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