A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
AstraZeneca
Study ID
NCT02637037
Phase
PHASE1
Status
Completed

Conditions

  • Bioequivalence
  • Fixed Dose Combination Tablets
  • Healthy Male and Female Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Key Dates

Start date
Dec 21, 2015
Status verified
Mar 2018
Primary completion
Apr 7, 2016
Completion
Apr 7, 2016

Study Design

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

Arms

  • Experimental: Treatment A
    Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose
  • Active Comparator: Treatment B
    Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose
  • Experimental: Treatment C
    Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose
  • Active Comparator: Treatment D
    Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose
  • Experimental: Treatment E
    Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose
  • Active Comparator: Treatment F
    Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose
  • Experimental: Treatment G
    Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose
  • Active Comparator: Treatment H
    Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose

Primary Outcome Measure

Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State [ Time Frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBaltimoreMaryland21225-

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Research Site· Baltimore, MD

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