KCT0000793已完成未知
Evaluation of Safety, Tolerability, and Pharmacokinetic Characteristics of DA-6034 in Healthy Volunteers
Dong-A Pharm0 个研究点目标入组 67 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
- 67
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) Healthy male adult subjects aged 19 to 45 years who are considered to be suitable to participate in the study based on prior examination within 3 weeks before the study commencement
- •(2) Subjects with body weight of >45kg, and a within ±15% of ideal body weight
- •ideal body weight = (Height(cm)-100)*0.9
- •(3) Subjects who voluntarily decided to partipate and gave written consent.
- •(4) Subjects who are reliable, cooperative, obligible to limitations during the study
排除标准
- •(1) Subjects with a previous history or present abnormal symtoms of cardiology, respiratory, renal, hepatic, gastrointestinal, and neurologic diseases (especially myocardial infarction, stroke, hypotension (SBP/DBP < 90/50mmHg), uncontrolled hypertension(SBP/DBP > 150/95mmHg), coronary arterial diseases)
- •(2) Subjects with a previous history of clinically significant allergies (e.g. asthma)
- •(3) Subjects with hematological disorders
- •(4) Subjects with febrile disease or infectious diseases within 2 weeks before the study commencement
- •(5) Subjects who made whole blood donation within 2 months before the study commencement or blood component donation within 1 month before the study commencement
- •(6) Subjects who have participated in another clinical study within 30 days before the commencement of study
- •(7) Subjects with clinically significant neuropsychiatric disorders
- •(8) Subjects with a previous history of drug abuse
- •(9)Subjects with a previous history of drug allergies or other hypersensitivity reactions
- •(10) Subjects who are positive for HBs antigen, HCV antibody, or HiV antibody at prior examination
- •(11) Subjects who have continuous alcohol ingestion (>28 units/week) or do not agree to stop drinking during the study
- •(12) Smokers (except subjects who quit smoking before 3 months before the study commencement)
- •(13) Subjects who regularly administer over the counter medicine except prescribed medicine or vitamin/minerals
- •(14) Subjects who have used any drugs within 7 days before the study commencement
- •(15) Subjects who are permanently accommodated in a public institution
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