NCT01478529

A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation

A Single Dose, Open Label, Randomized, Two-period Cross Over Study in Healthy Male Subjects to Assess the Absolute Bioavailability of YM178 OCAS-M Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously.

Detailed description

All participants will receive both oral and iv formulations, separated by a washout period. Treatment arm A will receive a lower dose of mirabegron; Treatment arm B will receive a higher dose of mirabegron.

Conditions

• Pharmacokinetics of Mirabegron
• Bioavailability
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	mirabegron OCAS	oral administration
DRUG	mirabegron	iv administration

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2011-11-23
• Last updated: 2013-06-27

Locations

1 site across 1 country: Netherlands