relative bioavailability and bioequivalence of different formulations of opicapone in healthy volunteers

Conditions: Parkinson

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.


Eligibility criteria:
inclusion criteria: * a signed and dated informed consent form before any study-specific screening procedure was performed; * male or female subjects aged 18 to 45 years, inclusive; * body mass index (bmi) between 18 and 30 kg/m2 inclusive; * healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ecg); * negative tests for hepatitis b surface antigen (hbsag), anti- hepatitis c virus antibodies (hcv ab) and anti-human immunodeficiency virus antibodies (hiv-1 and hiv-2 ab) at screening; * clinical laboratory test results clinically acceptable at screening and admission to each treatment period; * negative screen for alcohol and drugs of abuse at screening and admission to each treatment period; * non-smokers or ex-smokers for at least 3 months; * able to participate, and willing to give written informed consent and comply with the study restrictions. * if female: * she was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective non-hormonal method of contraception \[intrauterine device or intrauterine system; condom or occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject\] for all the duration of the study; * she had a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each treatment period. 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.