This is a phase I PK study in healthy males.
This is a phase I, open, repeated dose, randomised PK study in healthy males. The study will consist of 4 parallel groups (Groups 1-4). All groups will have a crossover design with 4 treatment periods, each lasting for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Nuvisan Pharma Services
Neu-Ulm, Germany
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24)
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)
Time frame: During 24 hours
Fluctuation of Levodopa Cmax/Cmin, Tau
Explore fluctuation of levodopa Cmax/Cmin, tau. Figures given are per performed statistical analysis.
Time frame: 16 hours
Levodopa Peak Plasma Concentration (Cmax)
Levodopa peak plasma concentration (Cmax)
Time frame: 24 hours
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