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

NCT04501640 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-12

Study results available
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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.

Conditions

  • Pharmacokinetics of Mirabegron
  • Food Effect
  • Healthy Chinese Subjects

Interventions

DRUG

mirabegron

Oral adminstration

Sponsors & Collaborators

  • Astellas Pharma China, Inc.

    lead INDUSTRY

Principal Investigators

  • Executive Director · Astellas Pharma China, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2020-10-14
Completion
2020-10-27
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501640 on ClinicalTrials.gov