Conditions: Epilepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: yes

Brief summary:
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers

Detailed description:
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases

Arms:
arm 1: Group A

* Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
* Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
* Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days arm 2: * Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
* Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
* Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days

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

Protocol document: