Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

Sponsor
Boehringer Ingelheim
Study ID
NCT02577315
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin — DRUG
    Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin
  • Metformin — DRUG
    Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin
  • Empagliflozin — DRUG
    Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin
  • Metformin — DRUG
    Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

Study Details

Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions

Key Dates

Start date
Sep 30, 2015
Status verified
Oct 2016
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

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

Arms

  • Experimental: Test - Empagliflozin/Metformin
    fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin, oral with 200 mL of water uder fed conditions
  • Experimental: Reference - Empagliflozin + Metformin
    free combination of 1 tablet of 25 mg Empagliflozin and 1 tablet of 1000 mg of Metformin, oral with 200 mL of water under fed conditions

Primary Outcome Measure

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration. ]

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