An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Cmax of amlodipine
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 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 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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 20 to 45 years at screening
- •BMI: 18~29.9kg/㎡
- •Body weight ≥50kg
- •Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
排除标准
- •Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
- •Subjects who have symptoms of an acute disease within 28days before first administration
- •Subjects who have clinically significant active, chronic disease
- •Subjects who fall under the criteria below in laboratory test
- •AST/ALT > UNL (upper normal limit) × 2
- •Total bilirubin > UNL × 1.5
- •CrCL < 50mL/min
- •CPK > UNL × 2.5
- •Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg)
- •Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests
研究组 & 干预措施
Sequence 1
- period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg
- period 2: receive CJ-30060 5/160/10mg
干预措施: CJ-30060 5/160/10mg (Drug)
Sequence 2
- period 1: receive CJ-30060 5/160/10mg
- period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg
干预措施: CJ-30060 5/160/10mg (Drug)
Sequence 1
- period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg
- period 2: receive CJ-30060 5/160/10mg
干预措施: Exforge® tab 5/160mg, Crestor® tab 10mg (Drug)
Sequence 2
- period 1: receive CJ-30060 5/160/10mg
- period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg
干预措施: Exforge® tab 5/160mg, Crestor® tab 10mg (Drug)
结局指标
主要结局
Cmax of amlodipine
时间窗: Up to 144 hours post-dose
Cmax of rosuvastatin
时间窗: Up to 72 hours post-dose
AUClast of valsartan
时间窗: Up to 48 hours post-dose
Cmax of valsartan
时间窗: Up to 48 hours post-dose
AUClast of amlodipine
时间窗: Up to 144 hours post-dose
AUClast of rosuvastatin
时间窗: Up to 72 hours post-dose
次要结局
- AUCinf of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)