Phase 1 N=18 Randomized Treatment

Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01304329 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Empa: Area Under the Curve 0 to Infinity (AUC0-∞) — 5571.70; 5685.69 nmol*h/L

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: BI 10773 (Drug); simvastatin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	5571.70; 5685.69	—
PRIMARY Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)	33.51; 33.93; 16.83; 17.65	—
PRIMARY Empa: Maximum Measured Concentration (Cmax)	774.06; 847.49	—
PRIMARY Simvastatin: Maximum Measured Concentration (Cmax)	7.88; 7.65; 1.51; 1.47	—
SECONDARY Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	5481.31; 5619.60	—
SECONDARY Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	31.82; 32.57; 14.86; 16.53	—

Summary

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.

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 (NCT01304329). 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.