NCT03020134已完成1 期
Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants
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
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants
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
- Double (Participant, Investigator)
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
- •Willing and able to provide written informed consent
- •Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
- •If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
- •If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
- •If female, negative pregnancy test during the screening period.
- •Others as specified in the detailed protocol
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.
- •Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
- •History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
- •Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
- •Others as specified in the detailed protocol
研究组 & 干预措施
PKGroup(Ravidasvir/Danoprevir/Ritonavir)
Experimental
Ravidasvir + Danoprevir/ Ritonavir
干预措施: Ravidasvir (Drug)
PKGroup(Ravidasvir/Danoprevir/Ritonavir)
Experimental
Ravidasvir + Danoprevir/ Ritonavir
干预措施: Danoprevir (Drug)
PKGroup(Ravidasvir/Danoprevir/Ritonavir)
Experimental
Ravidasvir + Danoprevir/ Ritonavir
干预措施: Ritonavir (Drug)
Placebo Group
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 40 days
次要结局
- Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)(Up to 24 weeks)
- Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state(Up to 24 days)
研究者
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