A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- plasma concentrations (Cmax)
研究概览
简要总结
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR
- •Healthy Subjects:
- •Have normal renal function
- •No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ.
排除标准
- •Evidence of hepatorenal or nephritic syndrome
- •Any clinically significant abnormal findings on medical history, physical examination,or clinical laboratory tests (other than those associated with controlled diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or related or causative diseases)
研究组 & 干预措施
FEP-TAZ
Cefepime and Tazobactam combination; IV infusion over a period of 90 minutes Healthy subjects, Mild and Moderate RI: 4 g (2 g FEP and 2 g TAZ) Severe RI and patients on HD: 2 g (1 g FEP and 1 g TAZ)
干预措施: Cefepime and Tazobactam combination (Drug)
结局指标
主要结局
plasma concentrations (Cmax)
时间窗: 48 hrs
Tmax The elimination half-life (t1/2),
时间窗: 48 hrs
次要结局
- Number of Participants With Abnormal Laboratory Values(14 days)
- Number of Participants With Adverse Events(14 days)