Phase 1
Completed N=18
Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin
Healthy
Source: ClinicalTrials.gov NCT01304329 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Empa: Area Under the Curve 0 to Infinity (AUC0-∞) — 5571.70; 5685.69 nmol*h/L
Summary
The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.
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 | — |
Eligibility Criteria
Inclusion criteria
- healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
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. Informational only — not medical advice.