KCT0000710招募中未知
Clinical trial to assess the pharmacokinetic characteristics of Lodivixx tab. 5/160mg in healthy male subjects
Hanlim Pharmaceutical0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- 18(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1) Years 20-45
- •2) Body weight=50kg and 18=BMI=29kg/m2
- •3) volunteer
排除标准
- •1) Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •2) Subject with symptoms of acute disease within 28days prior to study medication dosing
- •3) Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
- •4) Subject with clinically significant active chronic disease
- •5) Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. reanl failure with Creatinine clearance < 50mL/min
- •6) Clinically significant hypotension when screening period (SBP<100mmHg, DBP<60mmHg)
- •7) Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- •8) Use of any prescription medication within 14 days prior to study medication dosing
- •9) Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- •10) Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
- •11) Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives
- •12) Subject who is not able to taking the institutional standard meal
- •13) Subjects with whole blood donation within 60days, component blood donation within 20days
- •14) Subjects receiving blood transfusion within 30days prior to study medication dosing
- •15) Participation in any clinical investigation within 60days prior to study medication dosing
- •16) Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
- •17) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefluit juice
- •18) Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 28days prior to study medication dosing
- •19) Contined serum potassium concentration abnormal status (on baseline visit, <3.5mEq/L or >5.5mEq/L)
- •20) Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to requst or instruction by investigator
- •21) Severe renal insufficient subjects (cratinine clearance : less than 10mL/min)
- •22) Severe hepatic insufficient subjects,billiary cirrhosis, billiary obstruction and cholestasis patient
- •23) Combination with aliskiren in Diabetic pateint or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
研究者
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