NCT00362726已完成1 期
Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2006年9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
- 14
- 试验地点
- 1
- 主要终点
- To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
研究概览
简要总结
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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 18 to 50 years old with a BMI 18 to 32 kg/m2
排除标准
- 未提供
研究组 & 干预措施
A
Active Comparator
干预措施: Rosiglitazone maleate (Drug)
B
Active Comparator
干预措施: Atazanavir Sulphate (Drug)
C
Active Comparator
干预措施: Atazanavir Sulphate + Rosiglitazone maleate (Drug)
D
Active Comparator
干预措施: Atazanavir Sulphate + Ritonavir (Drug)
E
Active Comparator
干预措施: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate (Drug)
结局指标
主要结局
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
次要结局
- To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
- To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
研究者
研究点 (1)
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