Conditions: Parkinson
Keywords: Opicapone, Parkinson, Bial, BIA 9-1067
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief summary:
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.

Detailed description:
Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.

Arms:
arm 1: A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fed Washout Period (7days) Period 2: Fasted arm 2: A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fasted Washout Period (7days) Period 2: Fed

Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

Protocol document: