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Completed

NCT Number: NCT01301742

Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1245.58.1 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 finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance

Treatment and study plan

BI 10773

Drug

1 tablet single dose BI 10773 in the morning

Gemfibrozil

Drug

Gemfibrozil 600 mg bid for 5 days

Primary outcomes

  1. Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)

    Time frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

    Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.

    The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

  2. Total Empa: Maximum Measured Concentration (Cmax)

    Time frame: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

    Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.

    The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

Secondary outcomes

  1. Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)

    Time frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

    Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.

    The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Single Dose BI 10773 Co-administered With Multiple Doses of 600 mg Gemfibrozil Bid Compared to Single Dose Treatment of BI 10773 Alone in Healthy Volunteers - a Phase I, Open-label, Randomised, 2-way Crossover Trial

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 23, 2011
Registry last updated
Jun 18, 2014

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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