KCT0004287已完成未知
Clinical trial for Herb standardization project, sponsor-investigator trials, single dose, open study, Banhahoobak-tang extract tablet listed in Korean medical insurance coverage
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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 Study
入排标准
- 年龄范围
- 20(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 BMI(Body Mass Index) ranging from 18.0kg/? to 27kg/?
- •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. AST, ALT < normal twice , Creatinine normal range
- •5) After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
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 gathering 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 Kwangju Dongshin university hospital.
- •12)a person with inflammatory fever, weak and weak, a precaution of Banhahoobaktang tablet ext.
- •13)Those who donate whole blood within two months before the first day of administration or who have received a blood transfusion within one month of the first day of administration.
- •14)person who has an hypersensitivity to components and similar drugs of Banhahoobaktang tablet ext.
- •15)Volunteer who judged incongruent by tester through clinical examination center.
- •16)Patients who have had rashes, redness (redness due to redness), and itching by medicine so far
研究者
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