KCT0002283已完成未知
A randomized, open-label, single dose, 2-way crossover study to evaluate the pharmacokinetic characteristics of EL-1401 in comparison to the co-administration of nebivolol and rosuvastatin in healthy volunteers
Elyson Pharmaceutical0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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
- 19(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •(1) Healthy adult subject’s who is at least 19 years and under 55 years at screening
- •(2) BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 45kg
- •(3) Subject who don't have congenital or chronic diseases and have no abnormal medical examination results withn 3 years
- •(4) Suitable subject who is determined by ECG and laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug at screening.
- •(5) Subjects who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
- •(6) Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
排除标准
- •(1) Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •(2) Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •(3) Subjects who show alanine transferase or aspartate aminotransferase >2 times upper limit of normal range.
- •(4) Subjects who drink Alcohol> 210g/week within 6 months prior to the screening. (1 glass(250ml) of Beer(5%) = 10g, 1 glass(50ml) of Soju(20%)= 8g, 1 glass(125ml) of Wine(12%)= 12g)
- •(5) Subjects who take the medication involved in other clinical trials or bioequivalence test within three months before the first dose medication characters.
- •(6) Subjects who show hypotension (Systolic Blood Pressure < 90mmHg), hypertension (SBP >140mmHg) or Diastolic Blood Pressure > 90 mmHg at screening.
- •(7) Subjects who have history of alcohol or drug abuse, within 1year.
- •(8) Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- •(9) Smoker (=20 cigarettes/day)
- •(10) Subjects who takes ethical the count or over the count medicine within 10days before the first investigational product administration.
- •(11) Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
- •(12) Subjects who can increase risk due to clinical test and administration of drugs or have severe grade/ chronic medical, mental condition or abnormal laboratory test it that may interfere with the analysis of test results.
- •(13) Patients with hypersensitivity to the components of investigational drug.
- •(14) Patients with bronchospasm or asthma.
- •(15) Patients with metabolic acidosis.
- •(16) Patients with bradycardia (< 50 bpm) and atrioventricular block (2?and 3?).
- •(17) Patients with acute heart failure, cardiogenic shock or decompensated heart failure in need of inotropic treatment (intravenous).
- •(18) Patients with uncontrolled heart failure.
- •(19) Patients with severe peripheral circulatory disorders.
- •(20) Patients with sinus node dysfunction syndrome, including sinoatrial block.
- •(21) Patients with untreated pheochromocytoma.
- •(22) Patients with hepatic failure or liver function impairment.
- •(23) Patients with severe renal impairment of renal failure.
- •(24) Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •(25) Patients with myopathy.
- •(26) Patients who concomitantly administrated cyclosporine.
- •(27) Pregnant and lactating women, women who do not use appropriate methods of contraception.
- •(28) Subjects who are not able to comply with guidelines described in the protocol.
- •(29) Subjects who is determined by investigator’s decision as unsuitable for clinical trial participation.
研究者
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