NCT00599404已完成1 期
An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets
POZEN0 个研究点目标入组 18 人开始时间: 2008年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Pharmacokinetic profile following dosing with PN400
研究概览
简要总结
Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature
排除标准
- •Standard inclusion criteria for a study of this nature
结局指标
主要结局
Pharmacokinetic profile following dosing with PN400
时间窗: 24-hour PK on Day 1 & Day 10 of each treatment period
次要结局
- To evaluate the safety of PN400(Day 1-10 of each treatment period)
研究者
相似试验
已完成
3 期
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan ProcedureThrombosisNCT02846532Janssen Research & Development, LLC112
已完成
1 期
Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male VolunteersHealthyNCT02184312Boehringer Ingelheim96
Unknown
1 期
DP-R212 Pharmacokinetic Study Phase IHealthyNCT02814500Alvogen Korea36
撤回
1 期
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 MonthsPediatric Gastroesophageal Reflux DiseaseNCT02442752Takeda
已完成
1 期
ABSK091 Food Effect Study in Healthy SubjectsHealth, SubjectiveFood-drug InteractionNCT05533788Abbisko Therapeutics Co, Ltd13