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A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbidopa | Placebo Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Continuous 24 h administration |
| |
| Carbidopa |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and frequency of adverse events, withdrawal rate | 1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events | Up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma | Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC | Up to 2 days |
| Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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| Drug |
Continuous 24 h administration |
|
Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
| Up to 2 days |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D008750 | Methyldopa |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006834 | Hydrazines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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