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The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with carbidopa and ODM-104.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa formulation A | Experimental | Levodopa formulation A together with ODM-104 100 mg and carbidopa |
|
| levodopa formulation B | Experimental | levodopa formulation B together with ODM-104 100 mg and carbidopa |
|
| levodopa formulation C | Experimental | levodopa formulation C together with ODM-104 100 mg and carbidopa |
|
| Sinemet IR 100/25 mg | Active Comparator | Sinemet IR 100/25 mg together with ODM-104 100 mg |
|
| Half Sinemet CR 100/25 mg | Active Comparator | Half Sinemet CR 100/25 mg together with ODM-104 100 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa, carbidopa, ODM-104 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax) of levodopa | Peak Plasma Concentration (Cmax) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax) of carbidopa, 3-OMD and ODM-104 | Peak Plasma Concentration (Cmax) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
systolic blood pressure (BP) < 90 mmHg or > 150 mmHg after 10 minutes in supine position diastolic BP < 50 mmHg or > 90 mmHg after 10 minutes in supine position
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| Name | Affiliation | Role |
|---|---|---|
| Mika Scheinin, MD | CRST Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRST | Turku | 20520 | 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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| 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 |