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The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stalevo (levodopa/carbidopa/entacapone) | Experimental | 125mg or 75mg of levodopa during treatment period 1 in groups 1 and 2 respectively. 150mg or 100mg of levodopa during treatment period 2 in groups 1 and 2 respectively. |
|
| Sinemet (levodopa/carbidopa) | Active Comparator | 150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stalevo (levodopa/ carbidopa/ entacapone) | Drug | 150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day. | 2-11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin, AUCo-tau | each subject 3 PK days between 1-6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimmo Ingman | Orion Corporation, Orion Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Unit, Orion Pharma | Espoo | 02101 | 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 |
|---|---|
| C481098 | Stalevo |
| D007980 | Levodopa |
| D002230 | Carbidopa |
| C071192 | entacapone |
| C009265 | carbidopa, levodopa drug combination |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sinemet (levodopa/carbidopa) | Drug | 150 or 100 mg levodopa q.i.d. in 3.5 hr interval |
|
|
| 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 |