Conditions: Epilepsy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: yes

Brief summary:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Detailed description:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design to evaluate and compare the relative bioavailability and therefore the bioequivalence of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations (CTF versus TBM) after a single oral dose administration under fasting conditions

Arms:
arm 1: One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)

One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) arm 2: One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) arm 3: One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)

One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) arm 4: One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) arm 5: One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)

One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) arm 6: One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)

Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol document: