A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- Variance of Oral Bioavailability
研究概览
简要总结
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients
- •Presumed diagnosis of GERD
- •Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks
排除标准
- •cardiovascular instability
- •clinically significant laboratory abnormalities
- •use of warfarin, carbamazepine, phenytoin, or rifampin
研究组 & 干预措施
High dose
干预措施: pantoprazole (Drug)
Low dose
干预措施: pantoprazole (Drug)
结局指标
主要结局
Variance of Oral Bioavailability
时间窗: 1 day
Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was \>1.2.
次要结局
- Area Under the Concentration-time Curve (AUC)(Baseline to 24 hours post dose on Day 1)
- Half Life(1 day)
- Apparent Oral Clearance (Cl/F)(1 day)