Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets

Sponsor
Boehringer Ingelheim
Study ID
NCT02028767
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.

Key Dates

Start date
Jan 31, 2014
Status verified
Jun 2015
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: Fixed Dose Combination (FDC)
    12.5 mg Empagliflozin / 500mg metformin fixed dose combination
  • Active Comparator: Separate tablets
    Empagliflozin and Metformin tablets

Primary Outcome Measure

AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

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