NCT01469416已完成1 期
The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area-under-the-concentration curve (AUC) of rosuvastatin
研究概览
简要总结
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals, male or female, age 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam and laboratory evaluations
- •Subjects that take no other medications 2 weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications (except acetaminophen), dietary supplements, or drugs of abuse
- •Subjects with a SLCO1B1*1A genotype
- •Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- •Subjects able to abstain from grapefruit, grapefruit juice, orange juice, caffeinated beverages and/or alcoholic beverages from 3 pm the day before the study to completion of that study day.
- •Participants determined to have normal liver and kidney function as measured at baseline
- •BMI between 18.5 - 30 kg/m2
- •Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing
- •Be able to read, speak, and understand English
排除标准
- •Subjects with active medical problems
- •Subjects on chronic prescription or OTC medications that cannot be stopped 2 weeks prior to and during the study.
- •Subjects incapable of multiple blood draws (HCT <30 mg/dL)
- •Subjects with a history of rhabdomyolysis
- •Subjects with a history of drug-related myalgias
- •Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias
- •Subjects with a history of GI bleed or peptic ulcer disease
- •Subjects with a recent history of trauma
- •Subjects with a recent history of or upcoming plan of surgery
- •Subjects that smoke tobacco or have ongoing alcohol or illegal drug use
- •Subjects who are pregnant, lactating, or trying to conceive during the study period
- •Subjects allergic to rosuvastatin or clopidogrel or any known component of the medications
研究组 & 干预措施
Rosuvastatin
Active Comparator
干预措施: Rosuvastatin (Drug)
Rosuvastatin + clopidogrel
Experimental
干预措施: Rosuvastatin (Drug)
Rosuvastatin + clopidogrel
Experimental
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Area-under-the-concentration curve (AUC) of rosuvastatin
时间窗: Blood samples collected over a 48 hour period
次要结局
- Time to concentration maximum (Tmax) of rosuvastatin(predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose)
- Maximum plasma concentration (Cmax) of rosuvastatin(predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose)
研究者
研究点 (1)
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