Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.

Detailed description:
Single-centre, open-label, randomized, gender-balanced, crossover study with four consecutive single-dose treatment periods.

Arms:
arm 1: Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25 arm 2: Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25 arm 3: Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg arm 4: Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg

Interventions: intervention 1: BIA 9-1067 intervention 2: Sinemet® 100/25 mg
Intervention descriptions: intervention 1: 50 mg of BIA 9-1067 (single-dose) intervention 2: immediate-release levodopa/carbidopa 100/25 (single-dose).

Protocol document: