Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Plasma Drug Concentration
研究概览
简要总结
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.
详细描述
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more
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 were 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 18.0 and 30.0 kg/m2, inclusive.
- •Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- •Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
- •Subjects who had clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
- •Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
- •Subjects who were non-smokers or ex-smokers for at least 3 months.
- •(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
- •(If female) She had a negative pregnancy test (β-HCG) at screening and 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.
- •Subjects who had a clinically relevant surgical history.
- •Subjects who had any significant abnormality in the coagulation tests.
- •Subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the Sponsor before inclusion).
- •Subjects who had a history of relevant atopy or drug hypersensitivity.
- •Subjects who had a history of alcoholism or drug abuse.
- •Subjects who consumed more than 14 units of alcohol a week.
- •Subjects who had a significant infection or known inflammatory process at screening or admission to each treatment period.
- •Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
- •Subjects who had received fluoxetine within 5 weeks of admission to the first period.
- •Subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion.
- •Subjects who had previously received BIA 9-
- •Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
- •Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
- •Subjects who were vegetarians, vegans or have medical dietary restrictions.
- •Subjects who could not communicated reliably with the investigator.
- •Subjects who were unlikely to co-operate with the requirements of the study.
- •Subjects who were unwilling or unable to give written informed consent.
- •(If female) She was pregnant or breast-feeding.
- •(If female) She was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device) or she uses oral contraceptives.
研究组 & 干预措施
Group 1
Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
干预措施: BIA 9-1067 (Drug)
Group 1
Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
干预措施: Rasagiline (Drug)
Group 2
Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
干预措施: BIA 9-1067 (Drug)
Group 2
Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
干预措施: Rasagiline (Drug)
Group 3
Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
干预措施: BIA 9-1067 (Drug)
Group 3
Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
干预措施: Rasagiline (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma Drug Concentration
时间窗: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
次要结局
- Time of Occurrence of Cmax (Tmax)(pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose)
- AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration(pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose)