Skip to main content
OpenTrials
Completed

NCT Number: NCT01304329

Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1245.63.1 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

BI 10773

Drug

Medium dose oral administration

simvastatin

Drug

Medium dose oral administration

Primary outcomes

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

    Time frame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

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

    The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values.

  2. Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)

    Time frame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin.

    The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values.

  3. Empa: Maximum Measured Concentration (Cmax)

    Time frame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Maximum measured concentration of the analyte in plasma, per period.

    The geometric mean and geometric coefficient of variation (gCV) are adjusted values

  4. Simvastatin: Maximum Measured Concentration (Cmax)

    Time frame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Maximum measured concentration of the analyte in plasma, per period.

    The geometric mean and geometric coefficient of variation (gCV) are adjusted values.

Secondary outcomes

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

    Time frame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

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

    The geometric mean and geometric coefficient of variation (gCV) are adjusted values.

  2. Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

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

    The geometric mean and geometric coefficient of variation (gCV) are adjusted values.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 25, 2011
Registry last updated
Jul 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.