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Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levodopa/carbidopa oral formulation A | Experimental | LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. |
|
| levodopa/carbidopa oral formulation B | Experimental | LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa/carbidopa oral formulation A | Drug | Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carbidopa/levodopa serum level Efficacy of the delivery method | Carbidopa/levodopa serum level | 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khalaf Bushara, MD,FRCP | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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2 different assemblies with 2 different formulations (A, B) will be used.
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Double-blinded
| levodopa/carbidopa oral formulation B | Drug | Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD |
|
| 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 |