Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 9-1067
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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.