KCT0002418已完成未知
A study to assess pharmacokinetic interactions by evaluating the effect of red ginseng on CYP drug metabolizing enzymes and transporter in healthy Korean adults
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 15
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 o Limit（—）
- 性别
- Male
入选标准
- •1) Healthy Korean adult male aged = 19 years at the screening
- •2) body weight of = 50kg and within ± 20% of ideal body weight
- •? IBW (kg) = {height (cm) - 100} * 0.9
- •3) No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease
- •4) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, performed within 4 weeks prior to administration of study drug
- •5) Subject who understands a detailed explanation of the study protocol, voluntarily decides to participate and follow the study instructions, and signs Informed Consent
排除标准
- •1) Hypersensitivity to study drug (major ingredient or any other ingredient), or medical history of clinically significant hypersensitivity to any other drug or additives
- •2) Medical history that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
- •3) History of gastrointestinal disease (e.g., inflammatory bowel disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- •4) History of major injury, surgical operation, or suspected symptom of acute illness (severe infection, severe trauma, serious diarrhea or vomiting, etc.) within 4 weeks prior to the first administration of study drug
- •5) Systolic blood pressure = 140mmHg or < 115mmHg, diastoic blood pressure = 90mmHg or < 70mmHg in sitting position
- •6) History of a substance abuse
- •7) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
- •8) Participation in any other study within 3 months prior to the first administration of study drug (the completion date of previous study is the day of the last administration of study drug)
- •9) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug
- •10) History of excessive alcohol abuse (> 21units/week, 1 unit = 10g = 12.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period, or excessive smoking (> 10cigarettes/day)
- •11) Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (e.g., grapefruit juice(= 1L/day) within 7 days prior to administration of study drug)
- •12) Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL(Venereal Disease Research Laboratories))
- •13) Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •14) Patient with hereditary angioedema, a history of angioedema in the treatment of ACE(An angiotensin-converting-enzyme ) inhibitors or angiotensin II receptor blockers, and patient with primary hyperaldosteronism
- •15) Subject that is not eligible to participate at the discretion of principal investigator and study investigator
研究者
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