Phase 1 N=20 Randomized Treatment

Drug Interaction Study of Digoxin and BI 10773

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01306175 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) — 37.8; 39.9 ng-h/mL

Study Design & Population

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

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	—

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.

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 (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.