NCT00518297已完成1 期
Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2007年8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
- 22
- 试验地点
- 1
- 主要终点
- Safety Assessments
研究概览
简要总结
The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
- •Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test
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.
- •Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
- •Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration
研究组 & 干预措施
1
Active Comparator
干预措施: Raltegravir (Drug)
2
Active Comparator
干预措施: Atazanavir (Drug)
3
Active Comparator
干预措施: Atazanavir + Raltegravir (Drug)
结局指标
主要结局
Safety Assessments
时间窗: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge
Pharmacokinetic Assessments
时间窗: Days 5, 12, and 26
次要结局
未报告次要终点
研究者
研究点 (1)
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