Phase I open, randomized cross-over pharmacokinetic study.
The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open, randomized, multicenter study with crossover design in healthy males and females.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Clinical Research Services Turku CRST
Turku, Finland
Levodopa Peak Plasma Concentration (Cmax) and fluctuation of levodopa Cmax/Cmin, tau
Explore the Cmax of levodopa and fluctuation of levodopa Cmax/Cmin, tau
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Carbidopa Peak Plasma Concentration (Cmax)
Explore Cmax of carbidopa
Time frame: Blood samples collected frequently on day 7 for 24 hours.
3-OMD Peak Plasma Concentration (Cmax)
Explore Cmax of 3-OMD
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Cmax, tau
Explore Cmax, tau of levodopa
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Cmin, tau
Explore Cmin, tau of levodopa
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Area under the plasma concentration versus time curve (AUC)
Explore AUC of levodopa
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Carbidopa Area under the plasma concentration versus time curve (AUC)
Explore AUC of carbidopa
Time frame: Blood samples collected frequently on day 7 for 24 hours.
3-OMD Area under the plasma concentration versus time curve (AUC)
Explore AUC of 3-OMD
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Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Peak-trough fluctuation (PTF)
Explore PTF of levodopa
Time frame: Blood samples collected frequently on day 7 for 24 hours.