Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State

Sponsor
AstraZeneca
Study ID
NCT02223065
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects.

Key Dates

Start date
Sep 30, 2014
Status verified
Mar 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: Treatment A
    Single oral dose of saxagliptin tablet coadministered with dapagliflozin tablet
  • Experimental: Treatment B
    Single oral dose of FDC (fixed-dose combination) tablet

Primary Outcome Measure

Saxagliptin Maximum Observed Concentrations (Cmax) [ Time Frame: Day 1-3 (Period 1) and Day 8-10 (Period 2) ]

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