A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Mean plasma concentration-time curves of amoxicillin and clavulanic acid
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection.
详细描述
This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric patients will each receive a single dose of LP-001 in a fed state while 15 pediatric patients will each receive a single dose of Augmentin ES-600 in a fed state. 3-4 blood draws per patient will be attempted up to 8 hours post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LP-001 Arm
a novel amoxicillin/clavulanate formulation
干预措施: Amoxicillin potassium clavulanate (Drug)
Augmentin ES-600
Augmentin ES-600
干预措施: Amoxicillin potassium clavulanate (Augmentin ES-600) (Drug)
结局指标
主要结局
Mean plasma concentration-time curves of amoxicillin and clavulanic acid
时间窗: 6-8 hours post dose
Calculation of mean plasma
Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
时间窗: 6-8 hours post dose
Calculation of AUC
Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
时间窗: 6-8 hours post dose
Calculation of CMAX
次要结局
未报告次要终点