NCT00939757

Study of the Effect of Food on the Pharmacokinetics of Mirabegron

A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of food on the pharmacokinetics of a single oral dose of mirabegron in healthy male and female subjects.

Detailed description

Subjects will be assigned in a random order to receive 3 dosing regimens: 1. a single oral dose under a fasting condition; 2. a single oral dose with food (low fat breakfast); 3. a single oral dose with food (high fat breakfast).

Conditions

• Healthy
• Pharmacokinetics of Mirabegron

Interventions

Type	Name	Description
DRUG	mirabegron	oral tablet

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-07-15
• Last updated: 2013-06-26

Locations

1 site across 1 country: United States