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 Dang Pharmaceutical1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2011年6月最近更新: 2012年2月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Chong Kun Dang Pharmaceutical
入组人数: 30
试验地点: 1
主要终点: Dose-proportionality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.

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 54 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers
•Able to participate in all procedure
•SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
•Have given written informed consent

排除标准

•Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
•Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
•Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
•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.
•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.
•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)
•Have received an investigational drug within 60 days prior to the first IP administration
•Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration
•Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.
•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.
•Positive for Hepatitis B, Hepatitis C, HIV or syphilis