Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers

Exclusion Criteria

• •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, or had a clinically relevant surgical history;
• •Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;
• •Had a history of relevant atopy or drug hypersensitivity;
• •Had a history of alcoholism and/or drug abuse;
• •Consumed more than 14 units of alcohol per week \[1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)\];
• •Had a significant infection or known inflammatory process on screening or admission to each treatment period;
• •Had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
• •Had used medicines within 2 weeks of admission to first period that could affect the safety or other study assessments, in the Investigator's opinion;
• •Had previously received opicapone;
• •Had used any investigational drug or participated in any clinical trial within 90 days prior to screening;
• •Had participated in more than 2 clinical trials within the 12 months prior to screening;
• •Had donated or received any blood or blood products within the 3 months prior to screening;
• •Were vegetarians, vegans or had medical dietary restrictions;
• •Could not communicate reliably with the Investigator;
• •Were unlikely to co-operate with the requirements of the study;
• •Were unwilling or unable to give written informed consent;
• •If female:
• •She was pregnant or breast-feeding.