A Phase 1, Randomized, Double-Blind Study to Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) After Intravenous Administrations in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety assessed by number of abnormal 12 Lead ECG findings
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body Mass Index (BMI) between 18 to 32 kg/m2 (both inclusive).
- •Medical history without any major pathology.
- •A sustained supine systolic blood pressure <150 mm Hg or >90 mm Hg or a supine diastolic blood pressure <95 mm Hg or >50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position.
- •Glomerular filtration rate (GFR) > 80 mL/min, estimated by the Cockcroft-Gault equation.
排除标准
- •Use of cefepime and/or tazobactam within 60 days prior to study drug administration.
- •History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
研究组 & 干预措施
FEP-TAZ 4 g
FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days
干预措施: FEP-TAZ 4 g (Drug)
Placebo
placebo IV
干预措施: Placebo (Other)
结局指标
主要结局
Safety assessed by number of abnormal 12 Lead ECG findings
时间窗: every 8 hours
To measure the Area Under the Curve [AUC]
时间窗: 24 hrs
Safety assessed by number of abnormal physical examinations findings.
时间窗: every 8 hours
Safety assessed by number of abnormal clinical laboratory test result
时间窗: every 8 hours
Safety assessed by number of abnormal vital signs findings
时间窗: every 8 hours
To measure the Maximum Concentration
时间窗: 24 hrs
次要结局
未报告次要终点