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

Brief summary:
Single centre, open-label, randomised study in four parallel groups of healthy volunteers

Detailed description:
Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Arms:
arm 1: 900mg of eslicarbazepine acetate (ESL, BIA 2-093) arm 2: 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine arm 3: 450 mg of S-licarbazepine arm 4: 450 mg of Rlicarbazepine

Interventions: intervention 1: BIA 2-093 intervention 2: S-licarbazepine intervention 3: R-licarbazepine
Intervention descriptions: intervention 1: Tablets containing 900 mg intervention 2: capsules containing 225 mg intervention 3: capsules containing 225 mg

Protocol document: