To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately

Sponsor
AstraZeneca
Study ID
NCT01535677
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.

Key Dates

Start date
Apr 30, 2013
Status verified
Jul 2015
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

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

Arms

  • Experimental: 1
    5 mg dapagliflozin and 850 mg Glucophage in fasted state
  • Experimental: 2
    dapagliflozin/metformin (5 mg/850 mg) immediate release (IR) FDC in fasted
  • Experimental: 3
    5 mg dapagliflozin and 850 mg Glucophage in fed state
  • Experimental: 4
    dapagliflozin/metformin (5 mg/850 mg) IR FDC in fed state

Primary Outcome Measure

Area under the curve over the time (AUC) [ Time Frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose ]

Related Studies