NCT03288636已完成1 期
A Phase I Study to Assess the Pharmacokinetics and Safety of Single Dose of Ravidasvir and Danoprevir/r and Repeated Doses of Ravidasvir in Combination With Danoprevir/r in Healthy Volunteers.
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
- 18
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 19~28kg/m2
- •Healthy men or women based on history, physical examination, laboratory examination and ECG.
- •Female subjects should be surgically sterilized (bilateral tubal ligation, bilateral ovariectomy or hysterectomy); or are willing to use at least one of the following contraceptive methods within 30 days of the first administration of the study drug until the last administration: I Male partner vas deferens ligation; II. Non-hormonal contraceptive methods: intrauterine contraceptives, condoms, contraceptive sponges, septa, vaginal ring containing sizing gel or cream.
- •Male subjects should be surgically sterilized; or are willing to use at least one of the following contraceptive methods within 30 days from the first administration of the study to the last administration: I. Female partners abstinence during the study period (including no donation): II. Compounds use hormonal contraceptives (oral, vaginal, parenteral or transdermal); III. Subjects and / or their female partners use non-hormonal contraceptive methods: condoms, contraceptive sponges, membranes, intrauterine devices, Fine gel or cream of the vaginal ring.
- •If female, the pregnancy test result should be negative during the screening period.
- •Voluntary to sign the informed consent.
排除标准
- •History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.
- •A history of drug or food allergy.
- •Positive test in any of the HBsAg、HCV Ab、HIV Ab and Syphilis Ab.
- •Any of the AST、ALT、ALP、TBIL and DBIL exceed the upper limits of normal, or other laboratory test results exceeding the normal range and judged by the investigator to be clinically significant.
- •History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
- •Female who were during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
- •Female partners were fertile and unwilling to take reliable contraceptive measures.
- •Others as specified in the detailed protocol.
研究组 & 干预措施
Experimental
Experimental
PKGroup:
Ravidasvir + Danoprevir/ Ritonavir
干预措施: Danoprevir (Drug)
Experimental
Experimental
PKGroup:
Ravidasvir + Danoprevir/ Ritonavir
干预措施: Ritonavir (Drug)
Experimental
Experimental
PKGroup:
Ravidasvir + Danoprevir/ Ritonavir
干预措施: Ravidasvir (Drug)
Placebo
Placebo Comparator
Placebo Group:
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 40 days
Incidence of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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