pharmacokinetic-pharmacodynamic interaction between three different single doses of bia 9-1067 and a single-dose of controlled-release 100/25 mg levodopa/benserazide

Conditions: Parkinson's Disease (PD)

Summary: to investigate the effect of three single oral doses of bia 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (madopar hbs).

single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. the washout period between doses was to be at least10 days. on each treatment period (25, 50 and 100 mg bia 9-1067 or placebo), after completion of pre-dose assessments, bia 9-1067-placebo was to be administered concomitantly with the dose of madopar hbs; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.

Eligibility criteria:
inclusion criteria: * male subjects between 18 and 45 years, inclusive. * subjects of body mass index (bmi) between 19 and 30 kg/m2, inclusive. * subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ecg. * subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period. * subjects who had negative tests for hepatitis b surface antigen (hbsag), anti-hepatitis c antibodies (hcv ab), and human immunodeficiency viruses -1 and -2 antibodies (hiv-1 and hiv-2 ab) at screening. * subjects who had/were negative for drugs of abuse at screening and admission to each treatment period. * subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day. * subjects who were able and willing to give written informed consent. exclusion criteria: * subjects who did not conform to the above inclusion criteria, or * subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. * subjects who had a clinically relevant surgical history. * subjects who had a clinically relevant family history. * subjects who had a history of relevant atopy. * subjects who had a history of relevant drug hypersensitivity. * subjects who had a history of glaucoma. * subjects who had a history of alcoholism or drug abuse. * subjects who consumed more than 21 units of alcohol a week. * subjects who had a significant infection or known inflammatory process on screening or first admission. * subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn). * subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments. * subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission. * subjects who donated or received any blood or blood products within the previous 2 months prior to screening. * subjects who were vegetarians, vegans or have medical dietary restrictions. * subjects who could not communicate reliably with the investigator. * subjects who were unlikely to co-operate with the requirements of the study. * subjects who were unwilling or unable to give written informed consent. * subjects who were bial - portela \& cª, sa employees.

Keywords: parkinson's disease (pd) opicapone bia 9-1067