Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

Sponsor
Boehringer Ingelheim
Study ID
NCT01672788
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin — DRUG
    empagliflozin tablets and metformin tablet
  • Empagliflozin + Metformin — DRUG
    fixed dose combination tablet (low)
  • Metformin — DRUG
    empagliflozin tablets and metformin tablet
  • Metformin — DRUG
    empagliflozin tablet and metformin tablet
  • Empagliflozin + Metformin — DRUG
    fixed dose combination tablet (low)
  • Empagliflozin — DRUG
    empagliflozin tablet and metformin tablet

Study Details

The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

Key Dates

Start date
Aug 31, 2012
Status verified
Aug 2015
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

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

Arms

  • Experimental: Test 1
    fixed dose combination tablet
  • Active Comparator: Reference 1
    empagliflozin tablets and metformin tablet
  • Experimental: Test 2
    fixed dose combination tablet
  • Active Comparator: Reference 2
    empagliflozin tablet and metformin tablet

Primary Outcome Measure

Empa: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

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