The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
This study is an open-label study. The subjects will receive single administration of mirabegron in a fasted condition. After the non-dosing period, subjects will receive mirabegron for 8 days.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
Unnamed facility
Kyushu, Japan
Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h
Maximum concentration (Cmax), Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and AUC from time 0 to 24hr (AUC0-24h)
Time frame: Day 1-5 and Day 10, 11, 14-21
Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs
Time frame: Through day 25
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