NCT03753477已完成1 期
An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年12月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
详细描述
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject who provided written informed consent to participate in this study
- •Healthy adult male subjects aged 19 to 50 years
- •Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
- •Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results
排除标准
- •Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- •Subjects who had a serious clinical illness that can impact fate of drugs absorption
- •Subject who shows vital signs with the number of systolic blood pressure of >140 mmHg or <100 mmHg, and the number of diastolic blood pressure of >90mmHg or <65mmHg
- •Subject who have experienced drug abuse
- •Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)
- •Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication
研究组 & 干预措施
Test Drug
Experimental
DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
干预措施: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) (Drug)
Reference Drug
Active Comparator
Sevikar and Crestor
干预措施: Sevikar and Crestor (Drug)
结局指标
主要结局
AUC
时间窗: [ Time Frame: 0 - 72 hours ]
AUC
Cmax
时间窗: [ Time Frame: 0 - 72 hours ]
Cmax
次要结局
- CL/F([ Time Frame: 0 - 72 hours ])
- AUCinf([ Time Frame: 0 - 72 hours ])
- Tmax([ Time Frame: 0 - 72 hours ])
- t1/2β([ Time Frame: 0 - 72 hours ])
- Vdss/F([ Time Frame: 0 - 72 hours ])
研究者
研究点 (1)
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