NCT00470145已完成1 期
A Randomised, Single Blind, 2 Period, Crossover Study to Compare the Single Dose Pharmacokinetics and Tolerability of Formulations Containing Unmilled and Micronised SB-568859 in Healthy Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Comparison of the amount of SB-568859 found in the blood over a period of 6 days after a single dose of each of the two types of tablets
研究概览
简要总结
SB-568859 is a medication that is being developed for the treatment of atherosclerosis (hardening of the arteries). The purpose of this study is to see if there is a difference in how the human body takes up the study drug depending on how the study drug is made. This study will compare SB-568859 tablets that are made in 2 different ways. This is not a treatment study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and sterile women between 18 and 50 years old
- •Body weight greater than 50 pounds and a body mass index between 19 and 31
- •Normal electrocardiogram
排除标准
- •No history of asthma or severe allergic reactions
- •No history of or current drug use
- •No Hepatitis or HIV/AIDS
- •No excessive alcohol use
- •No smoking or tobacco use
- •No use of prescription drugs, over-the-counter drugs or vitamins within 7 days
- •No use of herbal supplements within 14 days
- •No treatment with an investigational drug within 30 days.
- •No treatment with 4 or more investigational drugs in the last 12 months
- •No grapefruit or grapefruit juice in the last 7 days
- •No donation of blood in the last 8 weeks
- •No history of allergy to heparin
- •No history of liver or gall bladder disease
- •Unwillingness to use contraception
结局指标
主要结局
Comparison of the amount of SB-568859 found in the blood over a period of 6 days after a single dose of each of the two types of tablets
时间窗: 6 days
次要结局
- Assessment of the safety and tolerability of SB-568859 after a single dose of each of the two types of tablets based on blood and urine tests, vital signs, electrocardiograms and reporting of side effects over a period of 6 days after each dose.(6 days)
研究者
研究点 (2)
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