Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design
Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases; Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Cmax - the Maximum Plasma Concentration
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Time frame: Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Time frame: Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration
Tmax - the Time of Occurrence of Cmax
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Time frame: Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration
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