KCT0000177尚未招募未知
Dose Block-randomized, Double-blind, Placebo Controlled, Single-dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of DWP10292 After Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 50
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
- All
入选标准
- •?A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- •?Healthy adult male subjects aged 20 to 45 years
- •?The subject has a Body weight = 60 kg and < 90 kg and Body Mass Index (BMI) = 18.5 kg/m2 and < 27.0 kg/m2
- •?A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
排除标准
- •1)A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history
- •2)subject who shows vital signs with the number of systolic blood pressure of =140 mmHg or =100 mmHg, and the number of diastolic blood pressure of =90mmHg or =60mmHg
- •3)A subject who shows the following result in clinical laboratory test:
- •?AST,ALT>1.25 times of the upper limit of normal range
- •?QTc>430msec
- •?T.bil>1.25 times of the upper limit of normal range
- •4)A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks
- •5)Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial.
研究者
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