Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YM150 low dose group | Experimental |
| |
| YM150 middle dose group | Experimental |
| |
| YM150 high dose group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of YM150 assessed by its plasma concentration change | for 7 days | |
| AUC of YM150 assessed by its plasma concentration change | for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa | for 7 days | |
| Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests | for 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu | Japan |
Not provided
| ID | Term |
|---|---|
| C569750 | darexaban |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | oral |
|