A Phase I, Single Center, Open Label, Two Groups Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 Hours and as 120-minute Intravenous Infusion Every 8 Hours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 主要终点
- Area under the concentration curve of Ceftaroline over the time (AUC).
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.
详细描述
A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Provision of informed consent prior to any study specific procedures.
- •Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
- •Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
- •Be willing to communicate with the investigator and comply with all study procedures.
排除标准
- •Creatine clearance <80 mL/min as calculated by the Cockcroft Gault equation
- •History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
- •Symptoms of any clinically significant illness within 2 weeks of screening.
- •Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit
- •Blood donation with 3 months of screening.
研究组 & 干预措施
Ceftaroline q8h
ceftaroline 600mg q8h
干预措施: Ceftaroline (Drug)
Ceftaroline q12h
Ceftaroline 600mg q12h
干预措施: Ceftaroline (Drug)
结局指标
主要结局
Area under the concentration curve of Ceftaroline over the time (AUC).
时间窗: Group 2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.
Maximum plasma concentration (Cmax) of Ceftaroline.
时间窗: Group2:Days 2 through 7: Pre-dose Day 8: Pre-dose, 60 min,90 min,115 min,125 min,2 hr15min,2.5hr,3 hr,4 hr,6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug
Area under the concentration curve of Ceftaroline over the time (AUC)
时间窗: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.
Maximum plasma concentration (Cmax) of Ceftaroline
时间窗: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.
次要结局
- Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).(Group2:Days 2 through 7:Pre-dose Day8: Pre-dose,60 min,90 min,115 min,125 min, 2 hr 15min,2.5hr,3 hr,4 hr,6hr,8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)
- Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)(Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr, 12hr, 18hr, 24hr after the start of infusion of the study drug.)
- Number of patients with adverse events.(From baseline to day 10)
- Area under the concentration curve of Ceftaroline fosamil over the time (AUC).(Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)
- Maximum plasma concentration (Cmax) of Ceftaroline fosamil(Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)