A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Treatment of Prevention of Stress Ulcer Bleeding (Ilaprazole i.v. vs Esomeprazole, i.v.)

The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable population by comparing the radio of upper gastrointestinal bleeding when they are administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection respectively.

Start Date16 Jul 2021

Sponsor / Collaborator

Livzon Pharmaceutical Group, Inc.

CTR20210784 / CompletedPhase 3

以注射用艾司奥美拉唑钠为阳性对照评价注射用艾普拉唑钠预防重症受试者应激性溃疡出血的疗效与安全性的多中心随机双盲平行分组的Ⅲ期临床试验

[Translation] A multicenter, randomized, double-blind, parallel-group phase III clinical trial using esomeprazole sodium for injection as a positive control to evaluate the efficacy and safety of ilaprazole sodium for injection in preventing stress ulcer bleeding in critically ill subjects

主要目的：通过评价使用注射用艾司奥美拉唑钠和注射用艾普拉唑钠预防重症受试者发生临床显著意义的上消化道出血的比例，对比其在预防重症受试者应激性溃疡出血的疗效；次要目的：评估和比较使用注射用艾司奥美拉唑钠和注射用艾普拉唑钠发生任何上消化道出血的比例；评估和比较使用注射用艾司奥美拉唑钠和注射用艾普拉唑钠发生任何上消化道出血的时间（单位：小时）；评价注射用艾普拉唑钠用于重症受试者的安全性和耐受性。

[Translation]

main purpose: To evaluate the proportion of clinically significant upper gastrointestinal bleeding in severe subjects using esomeprazole sodium for injection and ilaprazole sodium for injection, and compare their effectiveness in preventing stress ulcers in severe subjects Curative effect on bleeding; Secondary purposes: To assess and compare the proportion of any upper gastrointestinal bleeding occurring with esomeprazole sodium for injection and ilaprazole sodium for injection; To assess and compare the time (in hours) to the occurrence of any upper gastrointestinal bleeding with esomeprazole sodium for injection and ilaprazole sodium for injection; To evaluate the safety and tolerability of ilaprazole sodium for injection in critically ill subjects.

Start Date16 Jul 2021

Sponsor / Collaborator

Livzon Group Livzon Pharmaceutical Factory

CTR20133004 / RecruitingPhase 2

注射用艾普拉唑钠治疗消化性溃疡出血有效性和安全性的多中心、随机、双盲、阳性药物平行对照Ⅱ期临床试验

[Translation] A multicenter, randomized, double-blind, positive drug parallel controlled phase II clinical trial on the efficacy and safety of ilaprazole sodium injection in the treatment of peptic ulcer bleeding

探索注射用艾普拉唑钠治疗消化性溃疡出血/预防再出血的疗效和安全性，为Ⅲ期临床试验提供依据

[Translation]

To explore the efficacy and safety of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding/prevention of rebleeding and provide a basis for Phase III clinical trials

Start Date20 Feb 2014

Sponsor / Collaborator

Lizhu Group Lizhu Medicine Research Institute

[+1]

100 Clinical Results associated with Sodium ilaprazole

100 Translational Medicine associated with Sodium ilaprazole

100 Patents (Medical) associated with Sodium ilaprazole

Literatures (Medical) associated with Sodium ilaprazole

01 Apr 2020·European Journal of Pharmaceutics and BiopharmaceuticsQ2 · MEDICINE

The study of intestinal absorption and biodistribution in vivo of proton pump inhibitors

Q2 · MEDICINE

Article

Author: Jin, Zhaolei ; Li, Qingpo ; Jiang, Xindong ; Li, Chunlong ; Hou, Xuemei ; Shen, Tianxiang ; Ji, Qiuzhi ; Wang, Wei ; Long, Hongxin ; Qiu, Weigen ; You, Jian

The major therapeutic strategy for acid-related gastrointestinal diseases in clinic is to reduce the excretion of gastric acid by oral administration of proton-pump inhibitors (PPIs). However, it is quite a challenge to study the oral absorption behaviors of PPIs considering their extreme instability under gastrointestinal environment. As a result, little information has been reported on PPI oral absorption so far, hindering the further development of PPI-contained oral preparations. Here, we first investigated the degradation rate of three representative PPIs, including ilaprazole, ilaprazole sodium and rabeprazole sodium. Then a modified in situ intestine absorption method in rat was established: through the temperature control by the heat exchangers, the perfusate was kept at physiological temperature only when passing through the intestine while it was maintained at 4 °C outside the intestine. Therefore PPIs could maintained sufficiently high stability under proper temperature control. Our data demonstrated that both ilaprazole and ilaprazole sodium exhibited significantly higher absorption efficiency than rabeprazole sodium did through the comparison of their apparent permeability coefficients and steady-state plasma concentrations after perfusion in the duodenum, jejunum, ileum and colon, mainly attributing to their more suitable oil-water partition coefficient. The duodenum could be the best site for the oral absorption of PPIs. Ilaprazole outperformed its sodium salt form with its stable absorption behavior in tested four intestinal segments. Furthermore, after intravenous or oral administration, ilaprazole exhibited a longer residence time and a higher accumulation in the stomach than in most of other tissues/organs. However, it was also found that the accumulation was heterogeneous and mainly located in mucosa cells of the stomach. Our further study indicated that there was no significant difference on the oral absorption efficiency of ilaprazole between female and male rats but ilaprazole underwent a faster metabolism in male rats after oral absorption. Our study provided a valuable guidance for the design of oral formulation and the optimization of PPI-contained formulations.

100 Deals associated with Sodium ilaprazole

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Peptic Ulcer Hemorrhage	CN	Livzon Group Livzon Pharmaceutical Factory	28 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	CN	Livzon Group Livzon Pharmaceutical Factory	30 Oct 2014
Hemorrhage	Phase 3	CN	Lizhu Group Lizhu Medicine Research Institute	30 Oct 2014
Peptic Ulcer	Phase 3	CN	Livzon Group Livzon Pharmaceutical Factory	30 Oct 2014
Peptic Ulcer	Phase 3	CN	Lizhu Group Lizhu Medicine Research Institute	30 Oct 2014
Stress ulcer	Phase 2	CN	Livzon Pharmaceutical Group, Inc.	16 Jul 2021
Duodenal Ulcer	Phase 2	CN	Lizhu Group Lizhu Medicine Research Institute	10 Oct 2014
Duodenal Ulcer	Phase 2	CN	Livzon Group Livzon Pharmaceutical Factory	10 Oct 2014
Gastric mucosal lesion	Phase 1	CN	Lizhu Group Lizhu Medicine Research Institute	23 Oct 2015
Stomach Ulcer	Phase 1	CN	Lizhu Group Lizhu Medicine Research Institute	23 Oct 2015
Stomach Ulcer	Phase 1	CN	Livzon Group Livzon Pharmaceutical Factory	23 Oct 2015

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