NCT02305017已完成1 期
Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Bial - Portela C S.A.0 个研究点目标入组 28 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Cmax - Maximum Plasma Concentration
研究概览
简要总结
Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more.
详细描述
Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more. In one period, subjects received three single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg OPC was administered alone.
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
- •Subjects who are able and willing to give written informed consent.
- •Male or female subjects aged between 18 and 45 years, inclusive.
- •Subjects of body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive.
- •Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- •Subjects who have negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
- •Subjects who have clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
- •Subjects who have a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
- •Subjects who are non-smokers or ex-smokers for at least 3 months.
- •(If female) She is not of childbearing potential by reason of surgery or, if of childbearing potential, she uses 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 is the sole partner of that subject) for all the duration of the study.
- •(If female) She has a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.
排除标准
- •Subjects who have 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.
- •Subjects who have a clinically relevant surgical history.
- •Subjects who have any clinically relevant abnormality in the coagulation tests.
- •Subjects who have any clinically relevant abnormality in the liver function tests (a case-by-case decision for any abnormality must be discussed with the Sponsor before inclusion).
- •Subjects who have a history of relevant atopy or drug hypersensitivity, particularly to paracetamol or any COMT inhibitor.
- •Subjects who have a history of alcoholism or drug abuse.
- •Subjects who consume more than 14 units of alcohol a week.
- •Subjects who have a significant infection or known inflammatory process at screening or admission to each treatment period.
- •Subjects who have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
- •Subjects who have received paracetamol within 2 weeks of admission to the first period.
- •Subjects who have used any other medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
- •Subjects who have previously received OPC.
- •Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
- •Subjects who have participated in more than 2 clinical trials within the 12 months prior to screening.
- •Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
- •Subjects who are vegetarians, vegans or have medical dietary restrictions.
- •Subjects who cannot communicate reliably with the investigator.
- •Subjects who are unlikely to co-operate with the requirements of the study.
- •Subjects who are unwilling or unable to give written informed consent.
- •(If female) She is pregnant or breast-feeding.
- •(If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.
研究组 & 干预措施
Period 1 OPC + Paracetamol; Period 2 OPC
Experimental
Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
干预措施: BIA 9-1067 (Drug)
Period 1 OPC + Paracetamol; Period 2 OPC
Experimental
Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
干预措施: Paracetamol (Drug)
Period 1 OPC; Period 2 OPC+ Paracetamol
Experimental
Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
干预措施: BIA 9-1067 (Drug)
Period 1 OPC; Period 2 OPC+ Paracetamol
Experimental
Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
干预措施: Paracetamol (Drug)
结局指标
主要结局
Cmax - Maximum Plasma Concentration
时间窗: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration
次要结局
- AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.(before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose)
- AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification(before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose)
- Tmax - Time of Occurrence of Cmax(before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose)
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