A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

Sponsor
AstraZeneca
Study ID
NCT01055691
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin/Metformin — DRUG
    Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
  • Dapagliflozin — DRUG
    dapagliflozin tablet 2.5 mg Oral Single dose
  • Metformin — DRUG
    metformin IR tablet 850 mg Oral Single dose
  • Dapagliflozin/Metformin — DRUG
    Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
  • Dapagliflozin — DRUG
    dapagliflozin tablet 5 mg Oral Single dose
  • Metformin — DRUG
    metformin IR tablet 1000 mg Oral Single dose

Study Details

The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.

Key Dates

Start date
Jan 31, 2010
Status verified
May 2012
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

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

Arms

  • Experimental: 1
    Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
  • Experimental: 2
    Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
  • Experimental: 3
    Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
  • Experimental: 4
    Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets

Primary Outcome Measure

bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin. [ Time Frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP. ]

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