This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects.
The study will be of a double blind, randomized, two period crossover design. Two treatments, digoxin in combination with YM150, and digoxin in combination with placebo, will be evaluated. Each subject will receive both treatments in random order. Placebo will be used to maintain the blind. Males and females will be equally divided over the treatment orders. Subjects will be dosed with digoxin and either YM150 or placebo for 8 days to reach steady state. In the second period the subjects will receive digoxin and the alternate treatment. There will be a washout period of at least 10 days between the consecutive treatments. In both study periods the subjects will be admitted the day prior to study drug administration (Day 0). The subjects will be discharged on Day 10. Approximately one week after the last discharge, the subjects will return to the unit for a post study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
24
Unnamed facility
Paris, France
Cmax of digoxin assessed by its plasma concentration change
Time frame: for 24 hour after the last dose of each period
AUC of digoxin assessed by its plasma concentration change
Time frame: for 24 hour after the last dose of each period
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
Time frame: before dosing and 5hr after dosing on days 4 and 8 and 24h and 48h after the last dose
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
Time frame: for 10 days after dosing
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