NCT00772551已完成1 期
Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers
St Stephens Aids Trust1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination
研究概览
简要总结
Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female 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
- Treatment
- 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
- •The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- •Male or non-pregnant, non-lactating females
- •Between 18 to 65 years, inclusive
- •Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study
排除标准
- •Any significant acute or chronic medical illness
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- •Positive blood screen for hepatitis B and/or C antibodies
- •Positive blood screen for HIV-1 and 2 antibodies
- •Current or recent (within 3 months) gastrointestinal disease
- •Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
- •Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
- •Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within one week of first dose of study drug and for the duration of the study
- •Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
- •Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
- •Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
研究组 & 干预措施
1
Active Comparator
干预措施: Raltegravir and ezetimibe (Drug)
2
Active Comparator
干预措施: Ezetimibe and raltegravir (Drug)
结局指标
主要结局
Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination
时间窗: 41 days
次要结局
- Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure.(41 days)
研究者
研究点 (1)
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