Pharmacokinetics
Conditions
Keywords
Focus of the study is pharmacokinetics of the study drug
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.
Interventions
DRUGlevodopa, carbidopa
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 72 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Blood samples collected frequently on day 4 of both periods |
Countries
Finland
Outcome results
None listed