NCT00357721已完成1 期
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 18 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
- 18
- 试验地点
- 1
- 主要终点
- Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
研究概览
简要总结
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 BMI of 18 to 30 kg/m2
排除标准
- 未提供
研究组 & 干预措施
A1
Active Comparator
干预措施: Atazanavir Sulphate (Drug)
A2
Active Comparator
干预措施: Atazanavir Sulphate (Drug)
A3
Active Comparator
干预措施: Atazanavir Sulphate (Drug)
结局指标
主要结局
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
次要结局
- Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
- Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
- Assess the effect of atazanavir BID on metabolic parameters
- Assess the safety and tolerability of atazanavir when administered BID
研究者
研究点 (1)
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