KCT0000133尚未招募未知
A randomized, open-label, single dose, dose-rising 10-sequence, 3-period balanced incomplete blocked clinical trial to evaluate dose-proportionality of Dilatrend SR in healthy male volunteers
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
- 尚未招募
- 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 55(Year)（—）
- 性别
- Male
入选标准
- •1.Age range 20 to 54 years, Body mass index of =19 and =26 healthy male volunteers
- •2.Able to participate in all procedure
- •3.SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
- •4.Have given written informed consent
排除标准
- •1.Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
- •2.Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
- •3.Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
- •4.Have history of drug abuse. A positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, THC, methadone, ect.) included in the urine drug screen.
- •5.Have herbal drug within 30days prior to the first IP administration, have ETC within 14days prior to the first IP administration, have OTC 7days prior to the first IP administration.
- •6.Have diet which may influence on the absorption, distribution, metabolism or excretion of drug(s), (Drinking over 1L of grapefruit juice within 7days prior to the first IP administration)
- •7.Have received an investigational drug within 60 days prior to the first IP administration
- •8.Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration
- •9.Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.
- •10.A heavy caffeine/alcohol consumer or a heavy smoker(caffeine > 5 units/days. alcohol >21 units/week (1 unit=pure alcohol 10mL), Cigarette > 10 Cigarettes/day) or alcohol abuse.
- •11.Positive for Hepatitis B, Hepatitis C, HIV or syphilis
- •12.Inadequate result of laboratory test or ECG(AST(SGOT) or ALT(SGPT) or total bilirubin > 1.5 x upper limit of normal range in screening test)
研究者
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