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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304329
First Posted: February 25, 2011
Last Update Posted: July 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.

Condition Intervention Phase
Healthy Drug: BI 10773 Drug: simvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


  • 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.


  • 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


  • 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 Outcome Measures:
  • 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.


  • 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.



Enrollment: 18
Study Start Date: February 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment A, reference
1 tablet BI 10773, oral administration with 240 ml water
Drug: BI 10773
Medium dose oral administration
Experimental: treatment B, reference
1 tablet simvastatin, oral administration with 240 ml water
Drug: simvastatin
Medium dose oral administration
Experimental: treatment C, test
1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
Drug: BI 10773
Medium dose oral administration
Drug: simvastatin
Medium dose oral administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

- healthy male and female subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304329


Locations
Germany
1245.63.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01304329     History of Changes
Other Study ID Numbers: 1245.63
2010-023680-18 ( EudraCT Number: EudraCT )
First Submitted: February 21, 2011
First Posted: February 25, 2011
Results First Submitted: May 16, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Simvastatin
Empagliflozin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs