Phase 1
Completed N=20
Drug Interaction Study of Digoxin and BI 10773
Healthy
Source: ClinicalTrials.gov NCT01306175 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) — 37.8; 39.9 ng-h/mL
Summary
The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) |
37.8; 39.9 | — |
| PRIMARY Digoxin: Maximum Measured Concentration (Cmax) |
1.97; 2.25 | — |
| SECONDARY Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz) |
24.8; 28.4 | — |
Eligibility Criteria
Inclusion criteria
-Healthy male and female subjects
Exclusion criteria
-Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01306175). 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.