KCT0001729进行中（未招募）未知
Clinical trial to assess the pharmacokinetic/Pharmacodynamic characteristics and safety/tolerability of CKD-519 new formulation in healthy male subjects
Chong Kun Dang0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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.Between 20 aged and 45 aged in healthy male adult
- •2.Body weight = 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
- •3.Subject who sign on an informed consent form willingly
- •4.Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
排除标准
- •1.Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
- •2.Have a acute disease within 28 days before the beginning of study treatment
- •3.Have a disease history that can effect drug absorption, distribution, metabolism, excretion
- •4.Have a clinically significant chronic disease
- •5.Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg
- •6.Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
- •7.Subject treated ethical drug within 14 days before the beginning of study treatment
- •8.Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
- •9.Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
- •10.Cannot take standard Meal
- •11.Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
- •12.Blood transfusion within 30 days
- •13.Taking drugs have received any other investigational drug within 90 days prior to the first dosing
- •14.Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day)
- •15.Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
- •16.Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
研究者
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