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

Part of paid clinical trials in Austin, Texas.

Sponsor
Boehringer Ingelheim
Study ID
NCT02106923
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 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 \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

Key Dates

Start date
Apr 30, 2014
Status verified
Jan 2017
Primary completion
Jun 30, 2014
Completion
Jul 31, 2014

Study Design

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

Arms

  • Experimental: High dose, fasted
    1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
  • Experimental: High dose, fed
    1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
  • Experimental: Low dose, fasted
    2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions

Primary Outcome Measure

AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boehringer Ingelheim Investigational SiteAustinTexas--

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Boehringer Ingelheim Investigational Site· Austin, TX

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