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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 10773
* Drug: simvastatin
* Drug: simvastatin
* Drug: BI 10773


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - healthy male and female subjects Exclusion criteria: - Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment A, reference<br>1 tablet BI 10773, oral administration with 240 ml water | Drug: BI 10773<br>* Medium dose oral administration<br>|
| Experimental: treatment B, reference<br>1 tablet simvastatin, oral administration with 240 ml water | Drug: simvastatin<br>* Medium dose oral administration<br>|
| Experimental: treatment C, test<br>1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water | Drug: BI 10773<br>* Medium dose oral administration<br>Drug: simvastatin<br>* Medium dose oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empa: Area Under the Curve 0 to Infinity (AUC0-∞) | 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. | 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 | 
| Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞) | 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. | 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 | 
| Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values | 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 | 
| Simvastatin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | 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. | 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 | 
| Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | 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. | 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 |