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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily
Digoxin 0.5 mg as single dose
1245.40.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.
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
Digoxin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of digoxin, per period.
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
Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)
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.
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
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