The purpose of this study is to evaluate safety and absorption, distribution and elimination
of mirabegron after oral administration to Chinese subjects.
Drug: YM178 (mirabegron)
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Full eligibility criteria for NCT01747564
Ages eligible for Study
20 Years to 44 Years
Genders 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
Received mirabegron beforehand
All locations for NCT01747564
View full eligibility
Tris trial is registered with FDA with number: NCT01747564. The sponsor of the trial is Astellas Pharma Inc and it is looking for 24 volunteers for the current phase.
Official trial title: A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects
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