jRCT2071210134已完成不适用
A Clinical trial for Resminostat in Healthy Volunteers to Investigate the Effect of Food
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 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
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Caucasian males aged between 20 (inclusive) and 45 years of age (inclusive) at the time informed consent is obtained.
- •Body Mass Index between 18.5 kg/m2 (inclusive) and 30.0 kg/m2 (inclusive) at the time informed consent is obtained.
- •Written informed consent obtained from the subject.
排除标准
- •Clinical significant medical history or concomitant disease of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- •History of surgery, such as gastrectomy, gastrointenstinal suture, or intenstinal resection that would potentially alter absorption of drugs. However, the history of appendicectomy is acceptable.
- •History of clinically significant hypersensitivity or allergy to any drugs or foods.
结局指标
主要结局
-
PK: Pharmacokinetic parameters
次要结局
未报告次要终点
研究者
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