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To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose group | Experimental |
| |
| Multiple dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM178 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of YM178 assessed by the plasma concentration changes | Up to 96 hours after administration | |
| Cmax of YM178 assessed by the plasma concentration changes | Up to 96 hours after administration | |
| t1/2 of YM178 assessed by the plasma concentration changes | Up to 96 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of YM178 | Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs | Up to 33 days |
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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 |
|---|---|---|---|---|---|---|
| Shanghai | China |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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