NCT04547894已完成1 期
A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses
适应症
干预措施
相关药物
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
- AUC of ASC09F
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.
详细描述
This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 18-45 (including boundary value), half men and half women.
- •Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
- •According to the medical history, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.
- •Unplanned pregnancy within half a year and willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration.
- •The pregnancy test of female subjects during the screening period is negative.
- •Those who voluntarily sign the informed consent.
排除标准
- •Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.
- •People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
- •Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
- •Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
- •Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
- •Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
- •Alcoholic or nonalcoholic fatty liver disease.
- •In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.
研究组 & 干预措施
ASC09F
Experimental
ASC09F one tablet at a time, once per day, up to 7 days.
干预措施: ASC09F (Drug)
结局指标
主要结局
AUC of ASC09F
时间窗: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Evaluate the Area under the plasma concentration versus time curve after
Cmax of ASC09F
时间窗: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.
次要结局
- Vd/F of ASC09F(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.)
- Evaluation of the safety of ASC09F in healthy volunteers(Up to 11 days)
- t1/2 of ASC09F(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.)
- Tmax of ASC09F(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.)
- CL/F of ASC09F(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.)
研究者
研究点 (1)
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