A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 23
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endoscopically proven GERD diagnosed within 6 months before study entry.
- •Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg
排除标准
- •History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
- •Subjects 6-11 years old unable to swallow tablets
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Plasma Decay Half-Life (t1/2)
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Terminal-Phase Volume of Distribution (Vz/F)
时间窗: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
Plasma Concentrations After Multiple Doses
时间窗: Hours 2 and 4 on Day 7
次要结局
未报告次要终点