A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin
研究概览
简要总结
A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects aged 65 - 85 years
- •A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m
- •Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.
排除标准
- •Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- •Subject judged not eligible for study participation by investigator
研究组 & 干预措施
Rosuvastatin 20 mg PO
Rosuvastatin 20 mg daily for 21 days
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin
时间窗: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic evaluation
Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin
时间窗: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic evaluation
Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin
时间窗: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic evaluation
次要结局
- lipid panel (low-density lipoprotein cholesterol in mg/dL)(Day 1 0 hour, Day 11 0 hour, Day 22 0 hour)
- lipid panel (Triglyceride in mg/dL)(Day 1 0 hour, Day 11 0 hour, Day 22 0 hour)
- lipid metabolites(Day -1 0 hour, Day 21 0 hour)
- lipid panel (Total cholesterol in units of mg/dL)(Day 1 0 hour, Day 11 0 hour, Day 22 0 hour)
- lipid panel (high-density lipoprotein cholesterol in mg/dL)(Day 1 0 hour, Day 11 0 hour, Day 22 0 hour)
研究者
Jae Yong Chung, MD, PhD
Professor
Seoul National University Hospital