ITMCTR1900002878招募中1 期
A single-center, randomized, double-blind, placebo-controlled, dose escalation study to observe the safety and efficacy of catalpol tablets in Chinese healthy subjects.
The First Affiliated Hospital, Zhejiang University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 45（—）
- 性别
- All
入选标准
- •1. Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent.
- •2. Aged 18 to 45 years old, both men and women;
- •3. Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg);
- •4. Subjects Can communicate well with the researchers and comply with the requirements of the entire study.
排除标准
- •1. According to comprehensive physical examination and laboratory test, the researchers were not identified as healthy subjects;
- •2. Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and respiratory, metabolic, nervous system, (especially the spastic diseases such as epilepsy), chronic infectious and other major diseases;
- •3. Allergic constitution: the persons allergic to two or more medicines, food and pollen or rehmannia;
- •4. History of hypoglycemia;
- •5. Drug abusenicotine or alcohol test positive;
- •6. Faint at the sight of blood or needle;
- •7. Blood donation or a history of acute blood loss (more than 400 mL) in 3 month of the study;
- •8. Participating in other clinical trials within the past 3 months;
- •9. Subject took over 5 cigarettes or Equivalent amounts of tobacco products every day in the past 3 months.
- •10. Drug abuse history in past 5 years or had ever used drugs inpast 3 months before screening.
- •11. Within 2 years prior to screening has a history of alcohol abuse, that drinking more than 3 units of
- •12. Alcohol of a day and 21 units of alcohol a week (1 = 350 mL beer, 120 mL liqueur, 30mL alcohol or 150 mL wine) ;
- •13. Pregnant or nursing women; Fertile woman cannot take effective appropriate precautions in 3 months after the study;
- •14. Subjects with acute disease during screening period;
- •15. Used any medicine in the last 2 weeks;
- •16. Female subjects did not take non-drug contraceptive measures within 14 days before enrollment;
- •17. Unsuitable to participate in the trial considered by the researchers.
研究者
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