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The purpose of the study is to investigate PK of levodopa in plasma after repeated doses of 3 levodopa formulations given in combination with carbidopa and ODM-104 and compared to the PK of standard IR and CR levodopa formulations in the same combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa formulation D | Experimental | Levodopa formulation D |
|
| Levodopa formulation E | Experimental | Levodopa formulation E |
|
| Levodopa formulation F | Experimental | Levodopa formulation F |
|
| Sinemet IR 100/25mg | Active Comparator | Sinemet IR 100/25MG |
|
| Sinemet CR 100/25mg | Active Comparator | Sinemet IR 100/25MG |
|
| ODM-104 100mg | Experimental | ODM-104 100MG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa, carbidopa, ODM-104 | Drug | Crossover design. Study treatments will be administered in randomized order 4 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax) of levodopa | Peak Plasma Concentration (Cmax) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit, Orion Pharma | Espoo | 02200 | Finland |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| D002230 | Carbidopa |
| C009265 | carbidopa, levodopa drug combination |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Carbidopa 20mg | Active Comparator | Carbidopa 20MG |
|
| Carbidopa 65mg | Active Comparator | Carbidopa 65MG |
|
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D008750 | Methyldopa |
| D006834 | Hydrazines |