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This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepezil 35 mg | Experimental | Donepezil 35 mg or placebo |
|
| Donepezil 70 mg | Experimental | Donepezil 70 mg or placebo |
|
| Donepezil140 mg | Experimental | Donepezil 140 mg or placebo |
|
| Donepezil 210 mg | Experimental | Donepezil 210 mg or placebo |
|
| Donepezil 280 mg | Experimental | Donepezil 280 mg or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DKF-310 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h | 1056h |
| Cmax | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h | 1056h |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital | Seongnam | South Korea |
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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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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |