Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)
研究概览
简要总结
The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults (18 years of age or older)
排除标准
- •Ertapenem or other beta-lactam allergy
- •Pregnant or breast feeding females
- •Body Mass Index (BMI) greater than or equal to 30
- •Abnormal lab values at baseline
- •Hypertension
- •Significant medical abnormality
- •Regular alcohol consumption
- •Significant nicotine use
研究组 & 干预措施
Ertapenem 1 gram intravenous (IV) 5 minute bolus
Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.
干预措施: ertapenem (Drug)
Ertapenem 1 gram IV 30 minute infusion
Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).
干预措施: ertapenem (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)
时间窗: 5 or 30 minutes post start of infusion on Day 3
Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.
Area Under the Curve From 48 to 72 Hours [AUC(48-72)]
时间窗: 0-24 hours after 3rd ertapenem dose
AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.
次要结局
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(3 days)
- Probability of Target Attainment (PTA)(Simulated Steady-State Exposure)