DDI Between BI Empagliflozin (10773) and Verapamil

Study Overview
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Brief Summary
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Relative bioavailability of BI 10773 given alone and together with verapamil

Official Title
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Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Verapamil
* Drug: BI 10773
* 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: Reference<br>single dose BI 10773 | Drug: BI 10773<br>* single dose BI 10773<br>|
| Active Comparator: Test<br>single dose BI 10773 + single dose verapamil | Drug: Verapamil<br>* single dose verapamil<br>Drug: BI 10773<br>* single dose BI 10773<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Time From 0 to Maximum Plasma Concentration (Tmax) | Time from last dosing to the maximum plasma concentration | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Terminal Elimination Rate Constant (λz) | Terminal elimination rate constant in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Terminal Half-life in Plasma (t1/2) | Terminal half-life of empagliflozin in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Mean Residence Time in the Body After Administration (MRTpo) | Mean residence time of empagliflozin (empa) in the body after oral administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Apparent Clearance in Plasma After Extravascular Administration (CL/F) | Apparent clearance of empagliflozin (empa) in plasma after extravascular administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Apparent Volume of Distribution Following an Extravascular Dose (Vz/F) | Apparent volume of distribution during the terminal phase following an extravascular dose. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration | 
| Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG). | Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events. | Day1 to Day 11 | 
| Assessment of Tolerability by Investigator | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable. | Within Day 15 to Day 25 |