Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets

Sponsor
Boehringer Ingelheim
Study ID
NCT02821910
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

Key Dates

Start date
Jul 20, 2016
Status verified
Feb 2020
Primary completion
Oct 1, 2016
Completion
Oct 31, 2016

Study Design

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

Arms

  • Experimental: High dose, fed
    1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
  • Experimental: High dose, fasted
    1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions
  • Experimental: Low dose, fed
    1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions

Primary Outcome Measure

Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) [ Time Frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration ]

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