Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Profile of Pharmacokinetics
研究概览
简要总结
This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
排除标准
- •History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
- •Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
- •Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
- •Use of any substance that could induce or inhibit drug metabolism enzymes
研究组 & 干预措施
Rosuvastatin and Olmesartan
A multiple-dose administration of rosuvastatin, a multiple-dose administration of olmesartan, and a multiple-dose administration of rosuvastatin and olmesartan, given orally with a washout period of 8 days between each administrations
干预措施: Rosuvastatin (Drug)
Rosuvastatin and Olmesartan
A multiple-dose administration of rosuvastatin, a multiple-dose administration of olmesartan, and a multiple-dose administration of rosuvastatin and olmesartan, given orally with a washout period of 8 days between each administrations
干预措施: Olmesartan (Drug)
Rosuvastatin and Olmesartan
A multiple-dose administration of rosuvastatin, a multiple-dose administration of olmesartan, and a multiple-dose administration of rosuvastatin and olmesartan, given orally with a washout period of 8 days between each administrations
干预措施: Rosuvastatin and olmesartan (Drug)
结局指标
主要结局
Profile of Pharmacokinetics
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only
Css,max, AUCtau
次要结局
- Profile of Pharmacokinetics(0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only)
研究者
Kyungsoo Park
Associate Professor
Severance Hospital