This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.
To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
oral
Unnamed facility
Kyushu, Japan
Plasma concentration of YM150 and its metabolites
Time frame: for 3 days after drug administration
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
Time frame: for 3 days after drug administration
PT (prothrombin time)
Time frame: for 3 days after drug administration
aPTT (activated partial thromboplastin time)
Time frame: for 2 days after drug administration
FXa (factor Xa) activity
Time frame: for 1 days after drug administration
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