KCT0006791已完成未知
A randomized, open-label, single-dose, crossover study to compare the safety, tolerability and pharmacokinetics of ginsenosides after oral administrations of fermented Red ginseng concentrate and Red ginseng concentrate in healthy volunteers
Kyung Hee University Hospital0 个研究点目标入组 16 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
- 16
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 45(Year)（—）
- 性别
- Male
入选标准
- •1) Subjects who agree to participate in this study and have given their written informed consent
- •2) Men aged 19 to 45
- •3) 55.0 = Body weight (kg) = 90.0 and 18.0 = BMI (kg/m2) < 27.0
- •4) Subject who was determined by investigator for eligibility in this study
排除标准
- •1) History of hepatic, gastrointestinal, circulatory, renal, respiratory, endocrine, neurologic, immunologic, hematologic, psychiatric system, neoplasm or tumor
- •2) History or ongoing of significant allergy of prescription or over-the-counter medication
- •3) History of gastrointestinal disease or operation which can affect absorption of IP (Except for appendectomy or hernia correction)
- •4) Subject who meets any of the following criteria at screening test
- •? At the vital sign check, systolic blood pressure under 90 mmHg or over 150 mmHg, or diastolic blood pressure under 60 mmHg or over 100 mmHg
- •? Hepatic insufficiency (liver enzymes in the blood (AST and ALT) over 1.5 times of upper limit of normal)
- •? At the electrocardiogram, QTc over 450 msec or manifestation or significant abnormal rhythm
- •5) History of drug abuse
- •6) Taking any prescription or traditional medication within 2 weeks or over-the-counter medication, dietary supplement or vitamins within 1 week before first investigational drug (IP) administration (but, in the investigator's judgment, when other conditions are suitable, the subject can participate in this trial.)
- •7) Taking inducing or depressing drug metabolizing enzyme such as barbital within 1 month before first IP administration.
- •8) Drinking consistently or unable stopping drinking from 3rd before the first administration date of IP to last visit.
- •9) Before first IP administration, whole blood donation within 2 months, apheresis blood donation within 1 month, or blood transfusion within 1 month
- •10) Participation in other clinical trials within 6 months before first IP administration (previous clinical trial's end date is the last administration day)
- •11) Smoker over 10 cigarettes per day for 3 months before the first IP administration or who unable to quit smoking from 3 days ago before the first IP administration to last visit
- •12) Subject who is unable to intake standard meal provided by the clinical trial center
- •13) Subject who is unable to read the trial contents such as the informed consent form or to understand this trial (e.g., who not able or limited ability to read to informed consent form)
- •14) Subjects who do not follow informed-consent rules, or who are judged by the investigator to be inappropriate for inclusion in the study
研究者
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