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
Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPDO-1603 | Experimental | 1 tablet contains memantine 20mg/donepezil 10mg |
|
| BPDO-16031,BPDO-16033 | Active Comparator | 1 tablet memantine 20mg and 1 tablet donepezil 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPDO-1603 | Drug | donepezil/mematine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of memantine and donpezil | pharmacokinetic properties | from baseline to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of memantine and donpezil | pharmacokinetic properties | from baseline to day 10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyundaipharm | Seoul | 06121 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40444644 | Derived | Choi M, Jin BH, Keum DH, Mo KH, Park MS, Lee J, Park S, Kim CO. Bioequivalence of a Donepezil/Memantine 10/20 mg Fixed-Dose Combination Versus Single-Component Tablets in Healthy Korean Males. Clin Pharmacol Drug Dev. 2025 Sep;14(9):710-716. doi: 10.1002/cpdd.1556. Epub 2025 May 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |