Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

Sponsor
Boehringer Ingelheim
Study ID
NCT01811953
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Key Dates

Start date
Mar 31, 2013
Status verified
Jun 2015
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

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

Arms

  • Experimental: 1 Empagliflozin/Metformin (T)
    fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
  • Experimental: 2 Empagliflozin/Metformin (T)
    fixed-dose-combination tablet, oral with 240 ml water under fed conditions
  • Experimental: 3 Empagliflozin + Metformin (R)
    tablets, oral with 240 ml water under fasted conditions
  • Experimental: 4 Empagliflozin + Metformin (R)
    tablets, oral with 240 ml water under fed conditions
  • Experimental: 5 Empagliflozin/Metformin (T)
    fixed-dose-combination tablet, oral with 240 ml water under fed conditions
  • Experimental: 6 Empagliflozin + Metformin (R)
    tablets, oral with 240 ml water under fed conditions

Primary Outcome Measure

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

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