jRCT2071210085已完成不适用
Clinical pharmacology study of K-237 in healthy adult volunteers
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
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 40age old under(—)
- 性别
- All
入选标准
- •(1) Subject is a healthy adult volunteer.
- •(2) Subject is between the ages of 20 and 40 years at the time of signing informed consent.
- •(3) Subject has a body mass index of 17.6 to 26.4 kg/m2 at Screening.
排除标准
- •(1) Subject has a supine blood pressure after resting for at least 5 minutes that is lower than 90 mmHg systolic or higher than 140 mmHg systolic, and lower than 40 mmHg diastolic or higher than 90 mmHg diastolic at Screening.
- •(2) Subject has used a drug (including over-the-counter drug) within 14 days before the administration of the study drug or a supplement within 4 weeks before the administration of the study drug, or those who need to use it during the study period.
- •(3) Subject has a current malabsorption, and those who had an operation on the gastrointestinal tract that may affect absorption (excluding appendectomy and treatment for hernia).
结局指标
主要结局
-
Adverse events and adverse drug reactions
次要结局
未报告次要终点
研究者
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