Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects

Sponsor
Boehringer Ingelheim
Study ID
NCT02230995
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • metformin — DRUG
    single dose of metformin given as tablets
  • empagliflozin/metformin — DRUG
    Single dose empagliflozin/metformin given as fixed-dose combination tablet
  • empagliflozin — DRUG
    single dose of empagliflozin given as tablet

Study Details

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Key Dates

Start date
Sep 30, 2014
Status verified
Jan 2017
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

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

Arms

  • Experimental: Fixed dose combination
    Single dose empagliflozin/metformin
  • Active Comparator: Single tablets combination
    single doses empagliflozin and metformin

Primary Outcome Measure

AUC0-tz of Empagliflozin in Plasma [ Time Frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration ]

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