NCT00065741已完成1 期
Botanical/Drug Interactions in HIV: Glucuronidation
National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.
详细描述
As per Brief Summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 未提供
排除标准
- •History of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption.
- •History of hepatic, renal, cardiovascular, gastrointestinal diseases.
- •Current gastrointestinal disturbance.
- •Receipt of any prescribed or over the counter medication or ingested CAM during the 30 days prior to study entry except: Over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines.
- •Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
- •Pregnancy or breastfeeding.
- •Allergy/sensitivity to study agent(s) or their formulations.
- •Active drug or alcohol abuse or dependence, which in the opinion of the investigator would interfere with adherence to study requirements or would endanger the subject's health while on study.
- •Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days.
- •Participation in any investigational drug studies within 30 days prior to study entry and during study.
研究者
研究点 (2)
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