Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

Phase 1 Completed 18 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

Summary

To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

Timeline

Start: 2011-02
Primary completion: 2011-05
Completion: —

Publications

Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	25 mg	Oral
Comparator	Gemfibrozil	Small molecule	600 mg	—

Indications

No indication recorded.