dosage form proportionality of opicapone to-be-marketed formulation

Conditions: Epilepsy

Summary: single-centre, open-label, randomized, two-sequence, two-way crossover study. the study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.

single-centre, open-label, randomized, two-sequence, two-way crossover study. the study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more. in group 1 the volunteers received a single oral dose of 25 mg opc. in group 2 the volunteers received a single oral dose of 50 mg opc

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 45 years, inclusive; * body mass index (bmi) between 19 and 30 kg/m²; * healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ecg; - negative tests for hepatitis b surface antigen (hbsag), anti-hepatitis c vírus (anti-hcv) antibodies, and anti-human immunodeficiency virus (hiv)-1/-2 antibodies 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 and willing to give written informed consent; * if female: she was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective nonhormonal 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; and she had a negative serum pregnancy test at screening and a negative urine pregnancy test on day -1 of each treatment period. exclusion criteria: * 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; * a clinically relevant surgical history; * any clinically relevant abnormality in the coagulation tests; * any clinically relevant abnormality in the liver function tests. if the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor; * a history of relevant atopy or drug hypersensitivity; * a history of alcoholism or drug abuse; * consume more than 14 units of alcohol a week; * a significant infection or known inflammatory process on screening or admission to each treatment period; * acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period; * used medicines within 2 weeks of admission to first period that could have affected the subject's safety or other study assessments in the investigator's opinion; * previously received opc. previous use of opc was documented by questioning the subjects; * used any investigational drug or participated in any clinical trial within 90 days prior to screening * participated in more than 2 clinical trials within the 12 months prior to screening; * donated or received any blood or blood products within the 3 months prior to screening; * vegetarians, vegans or have medical dietary restrictions; * not able to communicate reliably with the investigator; * unlikely to co-operate with the requirements of the study; unwilling or unable to give written informed consent; * if female: she was pregnant or breast-feeding; she had a positive serum pregnancy test; she was of childbearing potential and did not use an accepted effective contraceptive method or she used oral contraceptives.