A Randomized, Open, Three-dose (100 mg, 200 mg and 300 mg) Duplicate Bifunctional Crossover and Fixed 200mg Continuous Dose Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.
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
- •Age between 18-45 years old;
- •Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19~24kg/m2
- •Healthy men or women based on history, physical examination, laboratory examination and ECG.
- •no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days.
- •Female has negative pregnancy tests at the screening stage.
- •Voluntary to sign the informed consent.
排除标准
- •Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
- •Has a history of drug or food allergy.
- •Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
- •Laboratory tests out of normal range and judged by the investigators as clinically significant.
- •Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
- •Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception.
- •People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug.
- •Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug.
- •Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse.
- •Selected within the first 3 months had blood loss or blood donation of 200ml.
- •Participate in other clinical trials within the first 3 months of the study and received other study drug treatment.
- •In addition to the above, the investigators judged not suitable for participating in this clinical trial.
研究组 & 干预措施
GROUP 1
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 50mg (Drug)
GROUP 1
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 200mg (Drug)
GROUP 2
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 50mg (Drug)
GROUP 2
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 200mg (Drug)
GROUP 3
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 50mg (Drug)
GROUP 3
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 200mg (Drug)
GROUP 4
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 50mg (Drug)
GROUP 4
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 200mg (Drug)
GROUP 5
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 50mg (Drug)
GROUP 5
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 200mg (Drug)
GROUP 6
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 50mg (Drug)
GROUP 6
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
干预措施: Ravidasvir 200mg (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 27 days
Pharmacokinetics (blood draws, pre- and post-dose)
Peak plasma concentration (Cmax)
时间窗: 27 days
Pharmacokinetics (blood draws, pre- and post-dose)
次要结局
未报告次要终点