NCT03009474已完成1 期
Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
研究概览
简要总结
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
详细描述
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged 20 to 45 years at the screening
- •Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
- •Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
排除标准
- •Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
- •Subject who have symptoms, result from acute disease within 28days before first administration.
- •Subject who have chronic persisting disease with clinical significance.
- •Subject who fall under the criteria below in laboratory test.
- •AST/ALT > UNL (upper normal limit) x 2
- •Total bilirubin > UNL x 1.5
- •In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
- •CPK > UNL x 2.5
- •Subject who with low blood pressure with clinical significance at screening test.
- •(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)
- •Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.
研究组 & 干预措施
CJ-30060
Experimental
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
干预措施: Exforge tab 5/160mg, Crestor tab 10mg (Drug)
Exforge tab 5/160mg, Crestor tab 10mg
Active Comparator
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
干预措施: CJ-30060 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
时间窗: Up to 144 hours post-dose
次要结局
- Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)
- Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)
- Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)
- Half life (t1/2) of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)
- Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)
研究者
研究点 (1)
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