NCT01218347已完成4 期
Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin
研究概览
简要总结
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.
详细描述
Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled.
Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
- •Weight: Over 55 kg, within ±20% of ideal body weight
- •Must be reliable and willing to make themselves available during the study period
- •Must be willing to give blood sample for genotyping
排除标准
- •History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
- •History of a significant surgical resection of gastrointestinal tract except appendectomy
- •History or evidence of drug abuse
- •Use any medication during the last 14 days period before first dosing
- •Hypersensitivity to HMG-CoA reductase inhibitor
- •Judged to be inappropriate for the study by the investigator
研究组 & 干预措施
Rosuvastatin
Experimental
rosuvastatin treatment
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin
时间窗: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h
次要结局
- lipid panel(LDL,HDL,TG,Total cholesterol)(Day 1 0h, Day 22 0h)
- lipid metabolites(Day -1 0h, Day21 0h, 4h, 8h)
研究者
研究点 (1)
Loading locations...
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