KCT0002224已完成未知
Open-Label Clinical Study to Evaluate the Pharmacokinetics and Safety of AGM-130 after intravenousmicrodosingin Healthy Adult Volunteers
AnyGen0 个研究点目标入组 6 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
- 6
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 19 to 45 at the screening visit
- •2. Subject who is over 55kg and as a result of calculated Ideal Body Weight, subject who is within the range of ±20%
- •3. 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. history or clinical manifestation of clinically significant cardiovascular, respiratory, renal, endocrine, hematologic, digestive, central nervous, psychiatric disorder or malignant tumor;
- •2. history of gastrointestinal tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of fluconazole and omeprazole
- •3. significant hypersensitive or clinically significant hypersensitivity reactions to any drug compound or other azole medicines or additives
- •4. determined as not appropriate for study participant during healthy examination (medical history, physical exam, lab test, vital sign) at screening
- •5. history of drugs abuse
- •6. consumption of excessive caffeine, alcohol, and cigarette (caffeine: 5 cups/day, alcohol: 210g/week, cigarette: >10/day)
- •7 use of other clinical trial's investigational drug within 90 days prior to investigational study drug administration
- •8. use of drug metabolizing enzyme inducers or inhibitors such as barbiturates within 30 days prior to investigational study drug administration
- •9. donation of blood from 60 days or plasma from 30 days prior to investigational study drug administration
- •10. consumption of grapefruit-containing foods and beverages within 7 days prior to investigational study drug administration
- •11. use of any prescription medicines or herbal medicines within 14 days prior to investigational study drug administration or over-the-counter or vitamin preparations within 7 days before prior to investigational study drug administration
- •12. ineligible for participation in clinical trials due to other reasons
研究者
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