Drug Interaction Study of Digoxin and BI 10773
- Registration Number
- NCT01306175
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Digoxin plus BI 10773 (Test) Digoxin plus BI 10773 Tablets, oral administration with 240 mL water Digoxin alone (Reference) Digoxin Tablet, oral administration with 240 mL water
- Primary Outcome Measures
Name Time Method Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.
Digoxin: Maximum Measured Concentration (Cmax) 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose Maximum measured concentration of digoxin, per period.
- Secondary Outcome Measures
Name Time Method Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz) 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.
Trial Locations
- Locations (1)
1245.40.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany