Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-01-02 @ 8:24 AM
Study NCT ID:
NCT00939757
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2009-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Food on the Pharmacokinetics of Mirabegron
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: