NCT01489696

A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.

Detailed description

Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences. Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron. 24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction. Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences. Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin. 24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.

Conditions

• Cardiovascular
• Healthy Subjects
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	mirabegron	oral
DRUG	tamsulosin	oral

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-12-12
• Last updated: 2013-12-09

Locations

1 site across 1 country: United Kingdom