NCT04688580已完成早期 1 期
An Open-label, Crossover Study to Assess the Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Immediate- and Modified-release Formulations in Healthy Adult Volunteers
XWPharma1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年11月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Time to reach Cmax (Tmax)
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male of female participants who are 18 to 55 years of age, inclusive.
- •Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.
排除标准
- •Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological, or endocrine disorders, poor vision, or allergic disease including drug allergies, including immediate type hypersensitivity. A history of childhood asthma that has resolved is acceptable.
- •Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.
研究组 & 干预措施
XW10172
Experimental
干预措施: XW10172 (Drug)
结局指标
主要结局
Time to reach Cmax (Tmax)
时间窗: 12 hours
Maximum concentration (Cmax)
时间窗: 12 hours
Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)
时间窗: 12 hours
Trough concentration (Cmin)
时间窗: 12 hours
Apparent oral clearance (CL/F)
时间窗: 12 hours
AUC from time 0 extrapolated to infinity (AUC0-inf)
时间窗: 12 hours
Cmax and AUC ratios of metabolite to XW10172
时间窗: 12 hours
AUC over the dosing interval (AUCtau)
时间窗: 12 hours
Apparent terminal half-life (t1/2)
时间窗: 12 hours
次要结局
- Incidence, severity, and causality of AEs(Up to 14 Days)
研究者
研究点 (1)
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