NCT02169713

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Tamsulosin HCl in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the safety and tolerability of the combined administration of solifenacin, mirabegron and tamsulosin HCl.

Detailed description

This study is comprised of two study sequences with 2 investigational periods in each sequence. There will be a wash-out period between each investigational period. Patients will be admitted to the clinic until discharged after each investigational period.

Conditions

• Healthy Subjects
• Pharmacokinetics
• Drug-Drug Interaction (DDI)

Interventions

Type	Name	Description
DRUG	Mirabegron	Oral
DRUG	Solifenacin succinate	Oral
DRUG	Tamsulosin HCl	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-06-23
• Last updated: 2014-08-29

Locations

1 site across 1 country: Germany