NCT02548286已完成1 期
A Randomized, Open-label, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers(B)
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
- 53
- 试验地点
- 1
- 主要终点
- AUCt(Area Under the Plasma Concentration-time curve) of Candesartan
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs 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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer in the age of 19-45
- •Body weight ≥ 55 kg and in the range of calculated IBW ±20%
- •Subject without a hereditary problems, chronic disease and morbid symptom
- •Suitable clinical laboratory test values
- •Subject who sign on an informed consent form willingly
排除标准
- •Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
- •Gastrointestinal disease or gastrointestinal surgery
- •History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs
- •Galactose intolerance
- •Sitting systolic blood pressure ≥ 140 mmHg or< 90 mmHg, sitting diastolic blood pressure ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 beats per minute
- •Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
- •Serum Creatinine > upper limit of normal range
- •Subject treated metabolizing enzyme inducers or inhibitors within 1 month
- •Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
- •Subject treated Investigational product(include Bioequivalence test) within 3 months
- •Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
- •Continuously taking Alcohol > 21 units/week
- •Cigarette > 10 cigarettes/day
- •Subjects with planning of dental treatment or any surgery
- •Another clinical condition in judgement of investigator
研究组 & 干预措施
Candesartan and Amlodipine
Active Comparator
Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
干预措施: Candesartan 8mg (Drug)
Candesartan and Amlodipine
Active Comparator
Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
干预措施: Amlodipine 5mg (Drug)
CKD-330
Experimental
CKD-330 8/5mg, PO, 1day or 22day
干预措施: CKD-330 8/5mg (Drug)
结局指标
主要结局
AUCt(Area Under the Plasma Concentration-time curve) of Candesartan
时间窗: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
Cmax(Maximum Plasma Concentration) of Amlodipine
时间窗: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Cmax(Maximum Plasma Concentration) of Candesartan
时间窗: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
AUCt(Area Under the Plasma Concentration-time curve) of Amlodipine
时间窗: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
次要结局
- CL/F(Clearance/Bioavailability) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- tmax(Time to reach the maximum concentration) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- t1/2β(Time for C max to drop in half) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- t1/2β(Time for C max to drop in half) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- tmax(Time to reach the maximum concentration) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- CL/F(Clearance/Bioavailability) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
研究者
研究点 (1)
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