NCT02106767已完成1 期
The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian 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
- 16
- 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 effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 Asian volunteers of Han-Chinese/Japanese/Korean descent whose parents and grandparents are Han-Chinese/ Japanese/ Korean.
- •Healthy Caucasian volunteers of White/Caucasian/European-born descent whose parents and grandparents are White/Caucasian/European.
- •Male or female, ages 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 who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.
- •Subjects with the following genotype: SLCO1B1*1a and ABCG2 421CC.
- •Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use.
- •Subjects able to abstain from grapefruit, grapefruit juice, oranges, orange juice, caffeinated beverages and/or alcoholic beverages from 7am 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 18.0 - 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.
- •Subjects capable of providing informed consent and completing the requirements of the study.
排除标准
- •Subjects with active medical problems
- •Subjects on chronic prescription or OTC medication that cannot be stopped 2 weeks prior to and during the study.
- •Subjects incapable of multiple blood draws (HCT < 30mg/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 who 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 rifampin or any known component of the medications
- •Anyone who in the opinion of the study investigators is unable to do the study
研究组 & 干预措施
Rosuvastatin
Active Comparator
干预措施: Rosuvastatin (Drug)
Rifampin plus rosuvastatin
Experimental
干预措施: Rosuvastatin plus rifampin (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(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose)
- Maximum plasma concentration (Cmax) of rosuvastatin(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose)
研究者
研究点 (1)
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