Phase 1 Completed N=18 Randomized Treatment

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

Healthy

Source: ClinicalTrials.gov NCT01634100 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcomePrimary: Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) — 2240; 3020; 3400 nmol*h/L

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)	2240; 3020; 3400	—
PRIMARY Total Empa: Maximum Measured Concentration (Cmax)	301; 527; 373	—
SECONDARY Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	2200; 3000; 3350	—

Eligibility Criteria

Inclusion criteria

healthy male and female subjects

Exclusion criteria

any relevant deviation from healthy conditions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01634100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.