Effect of Encapsulation Upon Efavirenz Pharmacokinetics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Serum Levels of Efavirenz
研究概览
简要总结
We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-negative, proven by ELISA
- •Age: ≥ 18 years old
排除标准
- •Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.
研究组 & 干预措施
efavirenz
干预措施: Efavirenz (Drug)
over-encapsulated efavirenz
干预措施: Over-encapsulated efavirenz (Drug)
结局指标
主要结局
Serum Levels of Efavirenz
时间窗: 5th day of taking drug
Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.
次要结局
未报告次要终点