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Completed

NCT Number: NCT01811953

Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

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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

1276.8.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

Empagliflozin

Drug

medium dose oral administration

metformin

Drug

oral administration

empagliflozin/metformin

Drug

low dose of Empagliflozin

Primary outcomes

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

    Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

    AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin

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

    Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

    AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin

  3. Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin

    Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

    Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin

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

    Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

    Cmax: maximum measured concentration of the analyte in plasma for Metformin

Secondary outcomes

  1. Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin

    Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

    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

  2. Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin

    Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

    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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2013
Registry last updated
Jul 27, 2015

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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