Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax - the Maximum Plasma Concentration
研究概览
简要总结
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.
详细描述
Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.
Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.
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
- •Male or female subjects aged between 18 and 45 years, inclusive.
- •Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- •Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG at screening.
- •Subjects who had clinical laboratory tests clinically acceptable at screening.
- •Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
- •Subjects who were negative for alcohol and drugs of abuse at screening.
- •Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
- •Subjects who were 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 one of the following methods of contraception: doublebarrier, intra-uterine device or abstinence.
- •(If female) She had a negative pregnancy test at screening and admission to each study period.
排除标准
- •Subjects who do not conform to the above inclusion criteria, or
- •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 a clinically relevant family history.
- •Subjects who have a history of relevant atopy.
- •Subjects who have a history of any drug hypersensitivity.
- •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 on screening and/or first admission.
- •Subjects who have acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- •Subjects who have used medicines within 2 weeks of admission to first period.
- •Subjects who have participated in any clinical trial within 3 months prior to screening.
- •Subjects who have previously received BIA 2-
- •Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to screening.
- •Subjects who are vegetarians, vegans and/or have medical dietary restrictions.
- •Subjects who cannot communicate reliably with the investigation team.
- •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
Group A
- st period - 16 mL oral suspension 50 mg/mL
- nd period - Four 200 mg tablets
- rd period - One 800 mg tablet
干预措施: BIA 2-093 (Drug)
Group B
- st period - One 800 mg tablet
- nd period - 16 mL oral suspension 50 mg/mL
- rd period - Four 200 mg tablets
干预措施: BIA 2-093 (Drug)
Group C
- st period - Four 200 mg tablets
- nd period - One 800 mg tablet
- rd period - 16 mL oral suspension 50 mg/mL
干预措施: BIA 2-093 (Drug)
结局指标
主要结局
Cmax - the Maximum Plasma Concentration
时间窗: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
时间窗: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
时间窗: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005
Tmax - the Time of Occurrence of Cmax
时间窗: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
次要结局
未报告次要终点