To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
BIA 9-1067 OPC, Opicapone 5 mg
Entacapone 200 mg
placebo (four times a day)
Bial - Portela & Cª, S.A.
S. Mamede Do Coronado, Portugal
Cmax - Maximum Plasma Concentration of Levodopa
Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Time frame: 8 days
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa
Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.
Time frame: 8 days
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.
AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Time frame: 8 days
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity
AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.
Time frame: 8 days
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standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 OPC, Opicapone 15 mg
BIA 9-1067 OPC, Opicapone 30 mg