Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)

Who cannot join

• Any personal or family history of haemostatic disorder; 2. Consumption of more than 21 units (14 units for female subjects) of alcohol a week (1 unit corresponds to 1 glass of 12% wine [10 cL], 1 glass of 40% whisky [2.5 cL], 1 glass of 12% champagne [10 cL], 1 glass of 18% aperitif drink [7 cL] or 1 glass of 5% beer [25 cL]); 3. Use of nicotine replacement products such as patches, gum and/or electronic cigarettes within 3 months prior to the screening visit; 4. Significant infection or known inflammatory process at screening or admission to each treatment period; 5. Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period; 6. Symptomatic orthostatic hypotension (drop of > 20 mmHg in systolic blood pressure and/or > 10 mmHg in diastolic blood pressure) when moving from supine to standing position, together with other symptoms, e.g., dizziness; 7. Previous use of BIA 9 1067; 8. Use of any investigational drug or participation in any clinical study within 90 days or within 5 t1/2, whichever was longer; 9. Participation in more than 3 clinical trials within the 12 months prior to screening; 10. Donation (450 mL or more) or reception of any blood or blood products within the 3 months prior to screening; 11. Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons); 12. Unable to communicate reliably with the Investigator; 13. Unlikely to co operate with the requirements of the study; 14. Use of medicines within 28 days (or 5 t1/2 [whichever was longer]) of initiation of treatment intake i.e., use of any prohibited medications or use of any medicine which, in the opinion of the Investigator, may have affected subject safety or study assessments; 15. Clinically relevant history or presence of respiratory, gastrointestinal, hepatic, renal, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders; 16. Clinically relevant surgical history that could have interfered with the PK of the study medications; 17. No medication was permitted throughout the study, except for medications to treat AEs.
• 18. An abnormal hepatic function based on an overall assessment by the Investigator regarding medical history, physical examination and laboratory tests of hepatic function (alanine aminotransferase [ALT] > 1 x the upper limit of normal [ULN], aspartate aminotransferase [AST] > 1 x the ULN and total bilirubin > 1.5 x the ULN [confirmed by subsequent repeat testing]), as judged by the Chief Investigator. If a laboratory assessment was outside of the reference range at the local laboratory at the screening visit or at baseline, the assessment could have been repeated once, as soon as possible, and in any case before enrolment to rule out laboratory error; 19. Any clinically relevant findings in the laboratory tests, including any abnormality in the coagulation tests; 20. History of alcoholism or drug abuse; 21. Females pregnant or breastfeeding at screening; 22. Subjects with clinically relevant neurologic or psychiatric illness (including psychotic events like hallucinations); 23. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.