KCT0000787进行中（未招募）未知
A randomized, open-label, multiple-dose, crossover phase ? study to compare the pharmacokinetic characteristics and safety of Dilatrend SR capsule 32 mg and Dilatrend® tablet 25 mg
Chong Kun Dang0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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 35(Year)（—）
- 性别
- Male
入选标准
- •1)Between 20 aged and 35aged in healthy male
- •2)Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
- •IBW(kg) = {height(cm)-100}*0.9
- •3)Have not any congenital or chronic disease and medical symptoms.
- •4)Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
- •5)Agreement with written informed consent
排除标准
- •-Subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug.
- •-Clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on.
- •-Hypotension(SBP < 105mmHg or DBP < 65mmHg), Hypertension(SBP > 150mmHg or DBP > 100mmHg)
- •-Heart rate < 50times/minute
- •-Active liver disease or AST, ALT > 1.5*upper limit of normal range
- •-Creatinine clearance < 80mL/min
- •-Subject has a disease affecting drug's ADME or gastrointestinal surgery.
- •-Subject with symptoms of injured or acute disease within 28days before the first IP administration.
- •-Subject has a history of drug abuse or a positive reaction for drug abuse at the screening test for urine.
- •-Taking ETC medicine including oriental medicine within 14days before the first IP administration or Taking OTC medicine within 7days
- •-Subject takes an abnormal meal which affect the ADME of drug.
- •-Previously participate in other trial within 90days.
- •-Previously make whole blood donation within 60days or component blood donation within 30days before the first IP administration.
- •-Continued to be taking caffeine(caffeine > 5cup/day), drinking(alcohol > 21unit/week, 1unit = 10g = 12.5mL of pure alcohol) or during clinical trials can not be drunk or severe heavy smoker(cigarette > 10cigarettes/day).
- •-Subject with positive reaction about serum test(HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
- •-Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
- •-An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result.
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