KCT0001118招募中未知
Clinical trial for Herb standardization project, sponsor-investigator trials, phase 1 pharmacokinetic study.
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 50
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
- 19(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1)Volunteer; age range of 19-55 years, and male who has no medical problem.
- •2)Body weight over 55Kg and IBW ranging from +-20%.(IBW: {height(cm)-100}*0.9)
- •3)with no congenital or chronical diseases and internal medical examination result including ECG is clear.
- •4)suitable at clinical pathology examination including blood test, urin test.
排除标准
- •1)anyone who has liver, kidney, nervous system, respiratory system, immune system, musculoskeletal system, endocrine system diseases, or mental disorder and who has past history(hepatitis B, C). Especially galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- •2)anyone who has gastro-intestinal diseases(Chron's disease, ulcer, acute or chronic pancreatitis) and gastro-intestinal surgery(without appendectomy, hernitomy).
- •3)After 3min rest :
- •-systolic blood pressure: =90mmHg or =160mmHg.
- •-diastolic blood pressure: =60mmHg or =100mmHg.
- •4)average drinking quantity: Alcohol 30g/day or cannot stop drinking during this clinical test.
- •5)Anyone who takes beverage containing Xanthine 4 cups a day or more.
- •6)Anyone who smokes more than 20 cigarrettes or who can not stop smoking during blood gattering periods.
- •7)Anyone who has taken drug like barbiturates or has taken lots of Alcohol.
- •8)Anyone who has past history about drug abuse or who has possibility about misusing and abusing through physical checkup(Amphetamine, babiturates, cocaine, opioids, benzodia zepines and so on)
- •9)Volunteer who has taken herbal medicine within 30 days.
- •Volunteer who has taken professional medicine within 14days.
- •anyone who has taken general medicine within 10 days.
- •10)Volunteer who has been in Bioequivalence test or clinical demonstration within 90 days.
- •11)Volunteer who can not eat typical meal provided by Gwangju wonkwang university hospital.
- •12)Volunteer who judged incongruent by tester through clinical examination center.
研究者
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