Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

Sponsor
Boehringer Ingelheim
Study ID
NCT01844531
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal. The assessment of safety and tolerability will be an additional objective of this trial.

Key Dates

Start date
Apr 30, 2013
Status verified
Jun 2015
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

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

Arms

  • Experimental: FDC empagliflozin dose 1 and metformin
    fix dose combination tablet after intake of a high fat, high caloric meal
  • Active Comparator: empagliflozin dose 1 + metformin tablets
    single tablets after intake of a high fat, high caloric meal
  • Experimental: FDC empagliflozin dose 2 and metformin
    fix dose combination tablet after intake of a high fat, high caloric meal
  • Active Comparator: empagliflozin dose 2 + metformin tablets
    single tablets after intake of a high fat, high caloric meal

Primary Outcome Measure

AUC0-∞ for Empagliflozin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]

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