Conditions: Parkinson
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 85
Healthy volunteers: yes

Brief summary:
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.

Detailed description:

Arms:
arm 1: volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed arm 2: volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed arm 3: volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed arm 4: volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed arm 5: volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed arm 6: volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed

Interventions: intervention 1: BIA 9-1067 (clinical micronized, CM) intervention 2: BIA 9-1067 (to-be-marketed, TBM)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: