JPRN-UMIN000022061已完成未知
Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers - Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Clinical Trial Center, Kitasato University Hospital0 个研究点目标入组 12 人开始时间: 2016年4月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- 20years-old 至 45years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •Subjects will be excluded from the study by the following criteria. The investigator must ensure the criteria basically at the screening visit. 1. Subjects who have a disease of the respiratory system, the digestive system, cardiovascular system, kidney, blood, psychoneurosis or cancer, or who had history of their disease. 2. Subjects who have a surgical history of the digestive system or kidney. 3. Subjects who have an infection of the respiratory system, skin, eye, the digestive system or urinary tract. 4. Subjects who have a hypertension, hyperthyroidism or dysuria, or who had history of their disease. 5. Subjects who have history of epileptic fit or organic insult to the brain and who have possibility of an epileptic seizure. 6. Subjects who have an allergy to food and medicine or who had history of allergy. 7. Subjects who have hay fever (allergic rhinitis). 8. Subjects who smoke. 9. Subjects who showed positive results of Syphilis test, Hepatitis B surface antigen or Hepatitis C. 10. Subjects who had history of drug or alcohol abuse or who showed evidence of such abuse by the laboratory test at the screening. 11. Subjects took any drug or health food containing St Johns wort within 4 weeks before dosing and be judged not eligible for the enrollment of the study by the investigator. 12. Subjects who participated any clinical trials within 12 weeks before dosing of the first period. 13. Subjects who donated 200ml of blood within 4 weeks or 400ml within 12 weeks. 14. Subjects whom the investigator consider ineligible for the study.
研究者
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