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This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.
To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fast-fed sequence group | Experimental |
| |
| fed-fast sequence group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of YM150 and its metabolites measured by blood samples | for 3 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by AEs, vital signs, 12-lead ECG and lab tests | for 3 days after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu | Japan |
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