NCT01220232已完成1 期
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
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
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.
研究概览
简要总结
This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m
- •Total body weight >50 kg (110 lbs).
排除标准
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- •History of hypersensitivity to abacavir, lamivudine and/or lersivirine.
研究组 & 干预措施
Abacavir/Lamivudine
Active Comparator
干预措施: Abacavir/Lamivudine (Drug)
Lersivirine + Abacavir/Lamivudine
Experimental
干预措施: Abacavir/Lamivudine (Drug)
Lersivirine + Abacavir/Lamivudine
Experimental
干预措施: Lersivirine (Drug)
结局指标
主要结局
To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.
时间窗: 17 days
次要结局
- To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.(17 days)
研究者
研究点 (1)
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