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

Part of paid clinical trials in Austin, Texas.

Sponsor
Boehringer Ingelheim
Study ID
NCT01975220
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 combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Key Dates

Start date
Oct 31, 2013
Status verified
Aug 2016
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

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 low dose combination (FDC) tablets vs. 4 single tablets under fed conditions

Primary Outcome Measure

Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
1276.13.1 Boehringer Ingelheim Investigational SiteAustinTexas--

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1276.13.1 Boehringer Ingelheim Investigational Site· Austin, TX

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