A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- AUCT,ss
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 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
- •Healthy male
- •Age between 19 and 50
- •Subjects with BMI of 18~27 kg/m2 with a weight of 55kg or more
- •Subjects with SBP of 90~150 mmHg and DBP of 60~150 mmHg
- •Signed informed consent
排除标准
- •Presence of medical history or a concurrent disease
- •Has a history of hypersensitivity to IP ingredients
研究组 & 干预措施
Sequence A
Ezetimibe/Rosuvastatin -> Valsartan -> Valsartan and Ezetimibe/Rosuvastatin
干预措施: Valsartan (Drug)
Sequence A
Ezetimibe/Rosuvastatin -> Valsartan -> Valsartan and Ezetimibe/Rosuvastatin
干预措施: Ezetimibe/Rosuvastatin (Drug)
Sequence B
Valsartan -> Valsartan and Ezetimibe/Rosuvastatin-> Ezetimibe/Rosuvastatin
干预措施: Valsartan (Drug)
Sequence B
Valsartan -> Valsartan and Ezetimibe/Rosuvastatin-> Ezetimibe/Rosuvastatin
干预措施: Ezetimibe/Rosuvastatin (Drug)
Sequence C
Valsartan and Ezetimibe/Rosuvastatin -> Ezetimibe/Rosuvastatin -> Valsartan
干预措施: Valsartan (Drug)
Sequence C
Valsartan and Ezetimibe/Rosuvastatin -> Ezetimibe/Rosuvastatin -> Valsartan
干预措施: Ezetimibe/Rosuvastatin (Drug)
Sequence D
Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin-> Valsartan
干预措施: Valsartan (Drug)
Sequence D
Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin-> Valsartan
干预措施: Ezetimibe/Rosuvastatin (Drug)
Sequence E
Valsartan -> Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin
干预措施: Valsartan (Drug)
Sequence E
Valsartan -> Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin
干预措施: Ezetimibe/Rosuvastatin (Drug)
Sequence F
Valsartan and Ezetimibe/Rosuvastatin -> Valsartan -> Ezetimibe/Rosuvastatin
干预措施: Valsartan (Drug)
Sequence F
Valsartan and Ezetimibe/Rosuvastatin -> Valsartan -> Ezetimibe/Rosuvastatin
干预措施: Ezetimibe/Rosuvastatin (Drug)
结局指标
主要结局
AUCT,ss
时间窗: Day 1~Day 8
Cmax,ss
时间窗: Day 1~ Day 8
次要结局
未报告次要终点