Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
研究概览
简要总结
The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.
详细描述
This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks 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
- Male
- 接受健康志愿者
- 是
入选标准
- •aged between 18 and 45 years, inclusive.
- •had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- •were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- •had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
- •had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.
- •had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.
- •were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.
- •was able and willing to give written informed consent.
排除标准
- •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.
- •had a clinically relevant surgical history.
- •had a clinically relevant family history.
- •had a history of relevant atopy or drug hypersensitivity.
- •had a history of alcoholism or drug abuse.
- •consumed more than 14 units of alcohol a week.
- •had a significant infection or known inflammatory process at screening or admission to the first treatment period.
- •had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.
- •used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.
- •used any investigational drug or participated in any clinical trial within 3 months 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.
- •was a vegetarian, vegan or with medical dietary restrictions.
- •could not communicate reliably with the investigator.
- •was unlikely to co-operate with the requirements of the study.
- •was unwilling or unable to give written informed consent.
研究组 & 干预措施
BIA 5-453 Fasting
BIA 5-453 200 mg in fasting conditions
干预措施: BIA 5-453 (Drug)
BIA 5-453 Fed
BIA 5-453 200 mg in fed conditions
干预措施: BIA 5-453 (Drug)
结局指标
主要结局
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
时间窗: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Tmax - the time of occurrence of Cmax
时间窗: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 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
时间窗: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Cmax - the maximum plasma concentration
时间窗: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
次要结局
未报告次要终点