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Completed

NCT Number: NCT02106923

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

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males or females
  • Age 18-50 years (incl.)
  • Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
  • Subjects must be able to understand and comply with study requirements

Exclusion criteria

Any deviation from healthy condition

Treatment and study plan

1 tablet Empagliflozin/2 tablets Metformin XR

Drug

Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets

10 mg Empagliflozin/1000 mg Metformin XR

Drug

Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

1 tablet 10 mg Empagliflozin/3 tablets Metformin XR

Drug

Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets

2 tablets 5 mg Empagliflozin/750 Metformin XR

Drug

Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets

Primary outcomes

  1. 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

    Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

  2. 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 Metformin

    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

    Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point

  3. Cmax (Maximum Measured Concentration of the Analyte in Plasma, 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

    Maximum measured concentration of empagliflozin in plasma (Cmax).

  4. Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin

    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

    Maximum measured concentration of metformin in plasma

Secondary outcomes

  1. AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), 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

    Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).

  2. AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin

    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

    Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2014
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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