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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Hadassah Medical Center
Jerusalem, Israel
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
Time frame: Up to 2 days
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
Time frame: Up to 2 days
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
Time frame: Up to 2 days
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