Phase 1
Completed N=18
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
Healthy
Source: ClinicalTrials.gov NCT01301742 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) — 4708.33; 7462.74 nmol*h/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) |
4708.33; 7462.74 | — |
| PRIMARY Total Empa: Maximum Measured Concentration (Cmax) |
602.24; 692.59 | — |
| SECONDARY Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) |
4643.81; 7350.84 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
Data sourced from ClinicalTrials.gov (NCT01301742). 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.