NCT00894439已完成1 期
A Randomized, Open-label, Single-dose, 3-period Crossover Study to Describe the Pharmacokinetic Parameters of BLI-489 and Piperacillin When Administered Simultaneously Compared to When Each is Administered Alone.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 24 人开始时间: 2009年5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
- 24
- 主要终点
- Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
研究概览
简要总结
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening.
- •Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
- •Healthy as determined by the investigator on the basis of the screening evaluations.
- •Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.
排除标准
- •Presence of history of any disorder that may prevent the successful completion of the study.
- •History of drug abuse within 1 year.
研究组 & 干预措施
1
Experimental
干预措施: BLI-489/Piperacillin (Drug)
1
Experimental
干预措施: BLI-489 (Drug)
1
Experimental
干预措施: Piperacillin (Drug)
结局指标
主要结局
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
时间窗: 10 days
次要结局
- Safety as measured by the number of adverse events and serious adverse events.(10 weeks)
研究者
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