NCT01819870Unknown1 期
A Randomized, Open-label, Multiple-dose, Crossover Phase I Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32 mg and Dilatrend Tablet 25 mg in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.
详细描述
Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20 aged and 35aged in healthy male
- •Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
- •IBW(kg) = {height(cm)-100}*0.9
- •Have not any congenital or chronic disease and medical symptoms.
- •Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
- •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.
研究组 & 干预措施
Dilatrend SR capsule 32mg
Experimental
干预措施: Dilatrend SR capsule 32mg (Drug)
Dilatrend IR tablet 25mg
Active Comparator
干预措施: Dilatrend IR tablet 25mg (Drug)
结局指标
主要结局
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 48 hours sample) determined using the linear trapezoidal rule
次要结局
- In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min(0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period))
- In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf(0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period))
- In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max(0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period))
- In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max(0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period))
- In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½(0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period))
- Number of participants with adverse events(From 1day to 37 days)
研究者
研究点 (1)
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