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Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1(12.5㎠) | Experimental | drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠ |
|
| 2(25㎠) | Experimental | drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠ |
|
| 3(50㎠) | Experimental | drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil patch | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability evaluation | evaluation item
| -1d~20d |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics characteristic evaluation | evaluation item : donepezil conc. evaluation variable
| 1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASAN Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26014587 | Derived | Choi HY, Kim YH, Hong D, Kim SS, Bae KS, Lim HS. Therapeutic dosage assessment based on population pharmacokinetics of a novel single-dose transdermal donepezil patch in healthy volunteers. Eur J Clin Pharmacol. 2015 Aug;71(8):967-77. doi: 10.1007/s00228-015-1875-2. Epub 2015 May 28. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Drug |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |