KCT0003740已完成未知
A Randomized, open-label, parallel-group study to evaluate the safety and pharmacokinetic characteristics in Korean healthy subjects
Korea Yakult Corporation0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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 45(Year)（—）
- 性别
- All
入选标准
- •1) Healthy adults between 20 and 45 years of age male, female
- •2) A person over 55kg in weight and within ± 20 percent of ideal body weight
- •3) A person has agreed to participate in clinical trial before the start of the trial and has signed an informed consent
排除标准
- •1) A person taking antibiotics one month before taking investigational product
- •2) A person taking Antidiarrhea or Probiotics one month before taking investigational product
- •3) A person with suspected acute illness within 4 weeks before taking investigational product
- •4) A person with a history of gastrointestinal disease or gastrointestinal resection that may affect the absorption of investigational product
- •5) A person with a clinically relevant disease
- •6) A person with a history of gastric ulcer or duodenal ulcer in the past or a person with active duodenal ulcer
- •7) Any of the following
- •a. AST (SGOT) or ALT (SGPT)> 1.5 times the upper limit of the normal range of the laboratory
- •b. Total bilirubin> 1.5 times the upper limit of the normal range of the laboratory
- •8) A person with clinically relevant allergic diseases
- •9) A person with hypersensitivity to red ginseng products
- •10) A person taking ginseng and red ginseng products within 2 weeks before taking investigational product
- •11) A person participating in other clinical trials within 90 days before taking investigational product
- •12) A person taking medication that affects drug metabolism enzymes within 30 days prior to ingestion of the clinical trial or those taking drugs that will affect the clinical trial within 10 days or within 5 times of the half-life
- •13) A person has hypotensive or hypertensive during the screening test
- •14) A person with increased ocular pressure or suffering from diseases such as glaucoma or urine retention.
- •15) A person taking food that could affect the intake within 7 days before taking investigational product
- •16) A person can not eat meals given by the hospital
- •17) A person who donating blood within 60 days before taking investigational product or donating blood within 30 days
- •18) Continuous caffeine intake (caffeinated drinks> 5 cups / day) or a person who can not giving up drinking or excessive smokers (cigarettes> 10ea/day)
- •19) Pregnant or who has a pregnancy plan during this trial
- •20) A person who is deemed by the examiner to be ineligible for clinical trials
- •21) Illiterate
研究者
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