A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects
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Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h [ Time Frame: Day 1-5 and Day 10, 11, 14-21 ]
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)
Secondary Outcome Measures
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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Ages Eligible for Study:
20 Years to 44 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Body weight: (male) over 50.0kg and less than 80.0kg (female) over 40.0kg and less than 70.0kg
Body Mass Index: over 17.6 and less than 26.4 kg/m
Healthy judged by investigator or sub-investigator
Received any investigational drugs within 120 days before the screening assessment
Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
Received medication within 7 days before hospital admission
A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
History of drug allergies
With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases