jRCT2071240014已完成不适用
ONO-1110-03 : An Open-label Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-1110 after Single Oral Administration in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Healthy Japanese adult males
- •The subject is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
- •The subject has a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 (rounded down to 2 decimal places) at screening.
排除标准
- •An individual who is receiving treatment for or has a history of a respiratory, cardiovascular, psychiatric, neurological, gastrointestinal, immunological, hepatic, renal, hematopoietic, endocrine, or other disease
- •Subjects with current or perious history of severe allergy to drugs or food
- •The subject who is judged by the investigator or subinvestigator to be inappropriate as a subject of this study based on the results of screening tests
结局指标
主要结局
-
Plasma ONO-1110 concentrations and pharmacokinetic parameters
次要结局
- Adverse events(after administration of investigational product until the end of final examination)
研究者
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