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This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2020 5 mg tablet and tape | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2022 | Drug | The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite (or Profile) of Pharmacokinetics | Cmax, Area Under Curve, Tmax | predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hidetaka Hiramatsu | Neuroscience Cliical Development Section, Japan /Asia Clinical Research PCU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagoshima | Kagoshima-ken | Japan |
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| Placebo | Drug | Matching Placebo tablets and tape |
|