A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects

A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects

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.

Inclusion Criteria:

• 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
• Chinese subjects
• Healthy judged by investigator or sub-investigator

Exclusion Criteria:

• 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
• Glaucoma patient