A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose

Sponsor
AstraZeneca
Study ID
NCT01072578
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
  • Dapagliflozin — DRUG
    Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days

Study Details

The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.

Key Dates

Start date
Feb 28, 2010
Status verified
May 2012
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Calculation of derivation of pharmacokinetic variables [ Time Frame: Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5 ]

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