NCT00357240已完成1 期
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006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
- 56
- 试验地点
- 1
- 主要终点
- Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
研究概览
简要总结
The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18 to 32 kg/m2
排除标准
- 未提供
研究组 & 干预措施
A1
Active Comparator
干预措施: Atazanavir (Drug)
A2
Active Comparator
干预措施: Atazanavir/Ritonavir (Drug)
A3 I
Experimental
干预措施: Atazanavir/Ritonavir+Omeprazole (Drug)
A3 II
Experimental
干预措施: Atazanavir/Ritonavir+Omeprazole (Drug)
B1
Active Comparator
干预措施: Atazanavir (Drug)
B2
Active Comparator
干预措施: Atazanavir/Ritonavir (Drug)
B3 I
Experimental
干预措施: Atazanavir/Ritonavir+Omeprazole (Drug)
B3 II
Experimental
干预措施: Atazanavir/Ritonavir+Omeprazole (Drug)
结局指标
主要结局
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
次要结局
- PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
研究者
研究点 (1)
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