NCT01334905

A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers

A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.

Detailed description

A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.

Conditions

• Healthy Volunteer
• Pharmacokinetics of YM178

Interventions

Type	Name	Description
DRUG	YM178	oral

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-04-13
• Last updated: 2013-06-12

Locations

1 site across 1 country: Taiwan