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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Probenecid; Drug: Empagliflozin (BI 10773); Drug: Empagliflozin; Drug: Rifampicin

• Registration Number: NCT01634100
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2014-05-16
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-27
• Last Update Submitted: 2014-06-27
• Results First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

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
C (Test 2)	Empagliflozin (BI 10773)	Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily
A (Reference)	Probenecid	Empagliflozin (BI 10773), Film-coated tablet, single dose
A (Reference)	Rifampicin	Empagliflozin (BI 10773), Film-coated tablet, single dose
A (Reference)	Empagliflozin	Empagliflozin (BI 10773), Film-coated tablet, single dose
B (Test 1)	Rifampicin	Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose
B (Test 1)	Empagliflozin	Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose
C (Test 2)	Probenecid	Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily

Primary Outcome Measures

Name	Time	Method
Total Empa: Maximum Measured Concentration (Cmax)	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	Maximum measured concentration of total empa in plasma, per period.
Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)	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	Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1245.83.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany