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

Bial - Portela C S.A.0 个研究点目标入组 85 人开始时间: 2014年3月最近更新: 2025年3月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 85
主要终点: Cmax - Maximum Observed Plasma Concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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;
•She was pregnant or breast-feeding.

研究组 & 干预措施

BIA 9-1067 5 mg Sequence 1

Experimental

volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation