Phase 1
Completed N=16
DDI Between BI Empagliflozin (10773) and Verapamil
Healthy
Source: ClinicalTrials.gov NCT01276301 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Area Under the Curve 0 to Infinity (AUC0-∞) — 5190; 5340 nmol*h/L
Summary
Relative bioavailability of BI 10773 given alone and together with verapamil
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve 0 to Infinity (AUC0-∞) |
5190; 5340 | — |
| PRIMARY Maximum Measured Concentration (Cmax) |
785; 725 | — |
| SECONDARY Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) |
5140; 5280 | — |
| SECONDARY Time From 0 to Maximum Plasma Concentration (Tmax) |
1.50; 1.75 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) |
0.0573; 0.0531 | — |
| SECONDARY Terminal Half-life in Plasma (t1/2) |
12.1; 13.1 | — |
| SECONDARY Mean Residence Time in the Body After Administration (MRTpo) |
9.47; 9.95 | — |
| SECONDARY Apparent Clearance in Plasma After Extravascular Administration (CL/F) |
178; 173 | — |
| SECONDARY Apparent Volume of Distribution Following an Extravascular Dose (Vz/F) |
186; 195 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG). |
0; 0 | — |
| SECONDARY Assessment of Tolerability by Investigator |
100.0; 87.5; 0.0; 6.3; 0.0; 6.3 | — |
Eligibility Criteria
Inclusion criteria
healthy male and female subjects
Exclusion criteria
Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01276301). 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.