KCT0001419已完成未知
An Open-label, Randomized, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of Aronamin-gold and Impactaminpower Tablet After Single Dosing in Healthy Male Subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
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
- Male
入选标准
- •1. Healthy male Korean subject age 20 to 45 at the screening visit
- •2. Subject who is over 50kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20%
- •3. Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination, subject who is no pathological symptoms or findings.
- •4. 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. Subject who has history or presence of clinically significant disease in liver, pancreas, kidney, nervous system, respiratory system, endocrine system, blood•tumor, mental illness, cardiovascular system and urinary system.
- •2. As the results of clinical laboratory test included other reasons, subjects who is determined to be unsuitable about participation in clinical trial
- •3. In laboratory tests, the subject who shows the results that fall into any of the following
- •-Aspartate Aminotransferase or Alanine Aminotransferase > above 1.5times of normal range
- •-Total bilirubin > above 1.5times of normal range
- •4. Subject who takes investigational product of other clinical study within 60 days before the frist administration.
- •5. Subject who takes whole blood donation within 60 days or apheresis within 20 days before the first administration
- •6. Subject who is unable takes grapefruit or the fruit product during the clinical trial
- •7. Subject who takes some ethical drug or herbal medicine within 14 days or some Over The Counter within 7 days before the first administration (Based on the investigator's judgment, if other conditions are appropriate, it is possible to participate in clinical trials)
- •8. Subject who drinks consistently (above 21 units/week, 1unit=10g of pure alcohol) and can't stop drinking during the treatment period
- •9. Subject who smokes consistently (above 10cigarettes/day)and can't stop smoking during the treatment period
- •10. Subject who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •11. Subject who has medical history of use of durgs of abuse
- •12. Subjects who is determined to be unsuitable about participation in clinical trial
研究者
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