Conditions: Epilepsy
Keywords: Epilepsy Oxcarbazepine Eslicarbazepine Acetate BIA 2-093
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief summary:
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.

Detailed description:
Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.

Arms:
arm 1: BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period

BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid arm 2: BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period

BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od arm 3: oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period

OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid

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

Protocol document: