JPRN-jRCTs061210011招募中未知
Exploratory study of the relationship between stool bioactivity of TJ-54 ingredients (glycyrrhizin) and the pharmacokinetics of glycyrrhetinic acid during administration of Yokukansan in healthy subjects
Hanazaki Kazuhiro0 个研究点目标入组 22 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- All
入选标准
- •1. Japanese
- •2. Age 20 to 45 years old at the signing of infromed consent
- •3 BMI within the range 17 to 27
- •4. Written informed consent
排除标准
- •1. Having a history of drug allergies or food allergies
- •2. Pregnant woman, wishing to become pregnant, or breastfeeding
- •3. Participated in other clinical studies within 16 weeks
- •4. Collected or donated blood more than 400 mL within 12 weeks for men and 16 weeks for women
- •5. Having a history of serious liver disease, heart disease or blood disease
- •6. Those who cannot continue quit smoking from 2 days before administration of the test drug
- •7. Those who cannot stop drinking, and/or taking licorice / licorice-containing foods and drinks (including spices), and licorice-derived supplements from 7 days before administration of the test drug
- •8. Judged by doctors not to be suited for the study based on the results of screening tests and the tests the day before administration of the test drug
- •9. Positive for HCV antibody, HBs antigen, or HIV antigen
- •10. Refused virus testing
- •11. Judged by doctors not to be suited for the study
研究者
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