Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid

Study Overview
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Brief Summary
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The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

Official Title
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A Randomised, Open-label, Three-way Crossover Trial to Investigate the Effect of Rifampicin and Probenecid on Empagliflozin Pharmacokinetics in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Probenecid
* Drug: Rifampicin
* Drug: Empagliflozin
* Drug: Empagliflozin
* Drug: Rifampicin
* Drug: Probenecid
* Drug: Empagliflozin (BI 10773)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. healthy male and female subjects Exclusion criteria: 1. 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: A (Reference)<br>Empagliflozin (BI 10773), Film-coated tablet, single dose | Drug: Probenecid<br>* Probenecid<br>Drug: Empagliflozin<br>* BI Drug<br>Drug: Rifampicin<br>* Rifampicin<br>|
| Experimental: B (Test 1)<br>Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose | Drug: Rifampicin<br>* Rifampicin<br>Drug: Empagliflozin<br>* BI Drug<br>|
| Experimental: C (Test 2)<br>Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily | Drug: Probenecid<br>* Probenecid<br>Drug: Empagliflozin (BI 10773)<br>* BI Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose | 
| Total Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total empa in plasma, per period. | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point. | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |