To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).
Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
OPC, Opicapone
PLC, Placebo
controlled-release levodopa 100 mg/benserazide 25 mg
BIAL - Portela & Cª - Human Pharmacology Unit (UFH)
S. Mamede Do Coronado, Trofa, Portugal
Cmax - Maximum Observed Plasma Concentration of Levodopa
Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
AUC0-t - Area Under the Plasma Concentration-time Curve
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
AUC0-∞ - AUC From Time Zero to Infinity
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Tmax - Time to Cmax
Primary pharmacokinetic parameter: tmax - time to Cmax
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
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