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The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
This study is an open-label study. The subjects will receive single administration of mirabegron in a fasted condition. After the non-dosing period, subjects will receive mirabegron for 8 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mirabegron group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM178 (mirabegron) | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h | Maximum concentration (Cmax), Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and AUC from time 0 to 24hr (AUC0-24h) | Day 1-5 and Day 10, 11, 14-21 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs | Through day 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu | Japan |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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