Phase I Multiple-Ascending Dose (Japan)

Sponsor
AstraZeneca
Study ID
NCT00538174
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, once daily up, to 14 days
  • placebo — DRUG
    Tablets, Oral, 0 mg, once daily, up to 14 days

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days

Key Dates

Start date
Nov 30, 2007
Status verified
Mar 2015
Primary completion
May 31, 2008
Completion
May 31, 2008

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    2.5 mg
  • Experimental: Arm 2
    10 mg
  • Experimental: Arm 3
    20 mg
  • Placebo Comparator: Arm 4

Primary Outcome Measure

AEs, vital signs & physical exam [ Time Frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21 ]

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