A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast
研究概览
简要总结
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers
Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.
详细描述
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers.
In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- •Administration of other investigational products within 3 months prior to the first dosing
- •Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
研究组 & 干预措施
ARM1
In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
干预措施: YHP1604 (Drug)
ARM1
In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
干预措施: Temisartan/Amlodipine+Rosuvastatin (Drug)
ARM2
In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
干预措施: Temisartan/Amlodipine+Rosuvastatin (Drug)
ARM2
In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
干预措施: YHP1604 (Drug)
结局指标
主要结局
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast
时间窗: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs
Cmax, AUClast
次要结局
未报告次要终点