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

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ClinicalTrials.gov Identifier: NCT01304329
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 Drug: simvastatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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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


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01304329     History of Changes
Other Study ID Numbers: 1245.63
2010-023680-18 ( EudraCT Number: EudraCT )
First Posted: February 25, 2011    Key Record Dates
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