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A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

Food Effect Clinical Trial

Official title:
A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects

Clinical Trial Summary

This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants. This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants.

Clinical Trial Description

An open-label, randomized, 2-period, single oral dose crossover design at 2 dose levels in healthy Chinese male and female participants. Each participant took part in 2 periods separated by a washout of at least 10 days between investigational product (IP) administrations in each period. Participants were screened for up to 21 days prior to IP administration on day 1 of period 1. Eligible participants were admitted to the clinical unit on day -1 of each period and were confined until the last pharmacokinetic sample had been drawn within each period. PK samples were collected predose on day 1 of each period and at multiple time points following each dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04501640
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 4
Start date September 21, 2020
Completion date October 27, 2020
View Details
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