Relative Bioavailability of a Single Oral Dose of Digoxin (0.5 mg) When Administered Alone or in Combination With Multiple Oral Doses of BI 10773 (25 mg qd) in Healthy Male and Female Volunteers (an Open-label, Randomised, Two-way Crossover Study)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Digoxin alone (Reference)
Tablet, oral administration with 240 mL water
Intervention: Digoxin (Drug)
Digoxin plus BI 10773 (Test)
Tablets, oral administration with 240 mL water
Intervention: Digoxin plus BI 10773 (Drug)
Outcomes
Primary Outcomes
Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)