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The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.
An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-355A | Experimental |
| |
| CKD-355B | Experimental |
| |
| D797, D324 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-355A (D797/Memantine HCl 20mg) | Drug | once a day |
| |
| CKD-355B (D797/Memantine HCl 20mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of D324 | Max Concentration of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| AUCt of D324 | Area under the curve of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| Cmax of D797 | Max Concentration of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| AUCt of D797 | Area under the curve of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin of D324 | Min Concentration of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| Cmin of D797 | Min Concentration of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 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 |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
once a day |
|
| D797 | Drug | once a day |
|
| D324 (Memantine HCl 10mg) | Drug | twice a day |
|
| Tmax of D324 | Time of Max concentration of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| Tmax of D797 | Time of Max concentration of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| t½ of D324 | Half-life time of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| t½ of D797 | Half-life time of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |