Conditions: Epilepsy
Keywords: Eslicarbazepine acetate BIA 2-093
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 13
Healthy volunteers: yes

Brief summary:
The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.

Detailed description:
Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated by a washout of 10 or more days. During each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Arms:
arm 1: BIA 2-093 1200 mg (2 tablets 600 mg) ESL, Eslicarbazepine acetate

Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day). arm 2: Placebo (2 tablets matching BIA 2-093 600 mg tablets) PLC, Placebo

Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Interventions: intervention 1: BIA 2-093 intervention 2: Placebo intervention 3: Digoxin
Intervention descriptions: intervention 1: BIA 2-093 1200 mg once-daily intervention 2: matching placebo intervention 3: Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Protocol document: