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临床试验/jRCT2071210085
jRCT2071210085已完成不适用

Clinical pharmacology study of K-237 in healthy adult volunteers

Kowa Company, Ltd.0 个研究点目标入组 12 人开始时间: 2021年10月26日最近更新:

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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