A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets

INTERVENTION: Trade Name: SIRIO*30CPR EFF 25MG+100MG Pharmaceutical Form: Effervescent tablet INN or Proposed INN: Melevodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Effervescent tablet Route of administration of the placebo: Oral use Trade Name: SINEMET*50CPR 100MG+25MG Pharmaceutical Form: Tablet INN or Proposed INN: LEVODOPA DC.IT FU CAS Number: 59‐92‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ INN or Proposed INN: CARBIDOPA FU CAS Number: 28860‐95‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Parkinson s disease ; MedDRA version: 8.1 Level: LLT Classification code 10061536 Term: Parkinson's disease PRIMARY OUTCOME: Main Objective: To determine levodopa plasma level after repeated doses of V1512 in fluctuating PD patients, compared to standard levodopa/carbidopa Sinemet over the course of the day. Primary end point(s): Pharmacokinetic PK evaluation will take place with regard to the following parameters for L‐dopa and carbidopa, for each dose administration Cmax; Tmax; AUC0‐t. The following pharmacodynamic parameters will be recorded or derived Motor category based on information recorded in the diary cards; troublesome dyskinesia as recorded in the diary cards; UPDRS section III motor component; Preference test Secondary Objective: To correlate plasma levels of levodopa with ON time. To further characterize the safety profile for each treatment. INCLUSION CRITERIA: 1. Male or female, 30 to 70 years of age of any race; 2. A Body Mass Index between 18.5 and 29.9 kg/m2 inclusive ; 3. Clinical diagnosis according to the Brain Bank diagnostic criteria of idiopathic Parkinson s Disease 2 of 3 cardinal symptoms ‐ bradykinesia, rigidity, tremor ‐must be present, with a positive response to L‐dopa ; 4. Presence of fluctuations in motor performance with 3 9 hours inclusive of daytime OFF episodes; 5. At least 1 hour delay to ON time with afternoon doses; 6. Discontinued use of COMT inhibitors cathecol‐o‐methyl transferase for at least 2 weeks prior to study entry; 7. Stable doses of dopamine agonists or selegiline for at least 2 weeks before entry into the study; 8. Stable comorbidity for 4 weeks; 9. Female patients must be of non‐childbearing potential post‐menopausal or physically incapable of childbearing ; 10. Willing and able to give informed consent according to national legal requirements prior to initiation