Conditions: Epilepsy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.

Detailed description:
Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.

Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.

Arms:
arm 1: 1. st period - 16 mL oral suspension 50 mg/mL
2. nd period - Four 200 mg tablets
3. rd period - One 800 mg tablet arm 2: 1. st period - One 800 mg tablet
2. nd period - 16 mL oral suspension 50 mg/mL
3. rd period - Four 200 mg tablets arm 3: 1. st period - Four 200 mg tablets
2. nd period - One 800 mg tablet
3. rd period - 16 mL oral suspension 50 mg/mL

Interventions: intervention 1: BIA 2-093 intervention 2: BIA 2-093 intervention 3: BIA 2-093
Intervention descriptions: intervention 1: oral suspension 50 mg/mL intervention 2: 200 mg tablet intervention 3: 800 mg tablet

Protocol document: