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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.
Subjects will be assigned in a random order to receive 3 dosing regimens:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. mirabegron, lower dose | Experimental |
| |
| 2. mirabegron, higher dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mirabegron | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegron | 4-5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tacoma | Washington | 98418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497763 | Background | Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M, Sawamoto T, Grunenberg N, Keirns J. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013 Mar;35(3):333-41. doi: 10.1016/j.clinthera.2013.02.014. |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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