The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
150 or 100 mg levodopa q.i.d. in 3.5 hr interval
Phase I Unit, Orion Pharma
Espoo, Finland
To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day.
Time frame: 2-11 weeks
Cmin, AUCo-tau
Time frame: each subject 3 PK days between 1-6 days
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