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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron

Criteria

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