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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773; Drug: simvastatin

• Registration Number: NCT01304329
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Primary Completion: 2011-04
• Results First Submitted: 2014-05-16
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-02
• Last Update Submitted: 2014-07-02
• Results First Posted: 2014-07-28
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment C, test	BI 10773	1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
treatment A, reference	BI 10773	1 tablet BI 10773, oral administration with 240 ml water
treatment C, test	simvastatin	1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
treatment B, reference	simvastatin	1 tablet simvastatin, oral administration with 240 ml water

Primary Outcome Measures

Name	Time	Method
Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)	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: Area Under the Curve 0 to Infinity (AUC0-∞)	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.
Empa: Maximum Measured Concentration (Cmax)	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)	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

Name	Time	Method
Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	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.
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	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.

Trial Locations

Locations (1)

1245.63.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany