To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.
Single-centre, open-label, randomized, gender-balanced, crossover study with four consecutive single-dose treatment periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
50 mg of BIA 9-1067 (single-dose)
immediate-release levodopa/carbidopa 100/25 (single-dose).
Algorithme Pharma Inc.
Mount Royal, Quebec, Canada
Cmax - Maximum Observed Plasma Concentration (L-DOPA)
Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
Tmax - Time of Occurrence of Cmax Maximum Observed Plasma Concentration (L-DOPA)
Pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA). For tmax = time to Cmax values are presented as median with range values.
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (L-DOPA)
Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (L-DOPA)
Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
Cmax - Maximum Observed Plasma Concentration (3-OMD)
Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose
Tmax - Time to Occurrence of Cmax (3-OMD)
Pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD). For tmax = time to Cmax values are presented as median with range values.
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (3-OMD)
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Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (3-OMD)
Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
Cmax - Maximum Observed Plasma Concentration (Carbidopa)
Mean pharmacokinetic parameters of carbidopa
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
Tmax - Time to Occurrence of Cmax (Carbidopa)
Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (Carbidopa)
Mean pharmacokinetic parameters of carbidopa
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (Carbidopa)
Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose
Cmax - Maximum Observed Plasma Concentration (BIA 9-1067)
Mean pharmacokinetic parameters of BIA 9-1067
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
Tmax - Time to Occurrence of Cmax (BIA 9-1067)
Pharmacokinetic parameters of BIA 9-1067. For tmax = time to Cmax values are presented as median with range values.
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (BIA 9-1067)
Mean pharmacokinetic parameters of BIA 9-1067
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (BIA 9-1067)
Mean pharmacokinetic parameters of BIA 9-1067
Time frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.