Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Cmax (maximum concentration)
研究概览
简要总结
To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab
详细描述
The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Years 20-45
- •Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
- •volunteer
排除标准
- •Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •Subject with symptoms of acute disease within 28days prior to study medication dosing
- •Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
- •Subject with clinically significant active chronic disease
- •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. renal failure with Creatinine clearance < 50mL/min
- •Clinically significant hypotension when screening period (SBP < 100mmHg, DBP < 60mmHg)
- •Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- •Use of any prescription medication within 14 days prior to study medication dosing
- •Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- •Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
- •Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives
- •Subject who is not able to taking the institutional standard meal
- •Subjects with whole blood donation within 60days, component blood donation within 20days
- •Subjects receiving blood transfusion within 30days prior to study medication dosing
- •Participation in any clinical investigation within 60days prior to study medication dosing
- •Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker (cigarette > 10 cigarettes per day)
- •Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
- •Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- •Continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L)
- •Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
- •Severe renal insufficient subjects (creatinine clearance : less than 10mL/min)
- •Severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient
- •Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
研究组 & 干预措施
Exforge tab. 10/160mg
- amlodipine besylate (10mg as amlodipine)
- valsartan 160mg
干预措施: Exforge tab. 10/160mg (Drug)
Lodivixx tab. 5/160mg
- S-amlodipine nicotinate (5mg as S-amlodipine)
- valsartan 160mg
干预措施: Lodivixx tab. 5/160mg (Drug)
结局指标
主要结局
Cmax (maximum concentration)
时间窗: Valsartan : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48hr (15 points), S-amlodipine : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 120, 168hr (18 points)
AUC(area under curve)
时间窗: Valsartan : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48hr (15 points), S-amlodipine : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 120, 168hr (18 points)
次要结局
- Number of participants with adverse events(Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge)