Pharmacokinetic Study With Repeated Doses of Stalevo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.

Official Title
-----------------
Levodopa Concentration Profile After Repeated Doses of Stalevo

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: levodopa, carbidopa, entacapone
* Drug: levodopa, carbidopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained Male or female patients with idiopathic Parkinson's disease with either a stable drug response or mild and predictable end-of-dose wearing-off symptoms. Hoehn and Yahr stage 1-2.5 performed during the ON state. Treatment with 3-5 daily doses of levodopa/DDCI ± entacapone with a total daily levodopa dose in the range of 300-600 mg. Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 2 weeks prior to the first treatment period. Age within 30-72 years, inclusive. Exclusion Criteria: Secondary or atypical parkinsonism. Patients with moderate to marked wearing-off symptoms or any unpredictable OFF-periods. Patients with treatment-related peak-dose dyskinesia. Change in dose strength, daily dose or dosing frequency of any medicinal products used to treat other medical conditions than Parkinson's disease within 2 weeks. Use of any iron preparations or other chelating agents. Patients with a history of a laboratory abnormality consistent with, or clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness, which may influence the outcome of the study. History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma. Any abnormalities in laboratory values, vital signs or electrocardiogram (ECG) with clinical relevance. Patients using any antiparkinsonian drugs for rescue medication (including soluble levodopa formulations). Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors. Known hypersensitivity to active substances or to any of the excipients of the study drugs. Participation in other drug studies within 60 days prior to study entry Unsuitable veins for repeated venopuncture. Blood donation or loss of significant amount of blood within 60 days prior to the screening.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 72 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stalevo<br> | Drug: levodopa, carbidopa, entacapone<br> <br> |
| Active Comparator: levodopa/carbidopa<br> | Drug: levodopa, carbidopa<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Blood samples collected frequently on day 4 of both periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focus of the study is pharmacokinetics of the study drug