预约演示
更新于：2026-08-13
Omeprazole/Sodium Bicarbonate
奥美拉唑碳酸氢钠
更新于：2026-08-13
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C18H21N3NaO6S |
InChIKeyMTVLHMQYMWWRNF-UHFFFAOYSA-N |
CAS号774595-73-2 |
关联
53
项与 奥美拉唑碳酸氢钠 相关的临床试验CTR20251155
奥美拉唑碳酸氢钠干混悬剂（I）在健康研究参与者中的随机、开放、单剂量、两周期、双交叉空腹生物等效性试验
CTR20241836
奥美拉唑碳酸氢钠干混悬剂的人体生物等效性试验
CTR20231671
奥美拉唑碳酸氢钠胶囊随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
100 项与 奥美拉唑碳酸氢钠 相关的临床结果
登录后查看更多信息
100 项与 奥美拉唑碳酸氢钠 相关的转化医学
登录后查看更多信息
100 项与 奥美拉唑碳酸氢钠 相关的专利（医药）
登录后查看更多信息
4
项与 奥美拉唑碳酸氢钠 相关的文献（医药）2018-01-01Clinical pharmacology in drug development
Acid Inhibitory Effect of a Combination of Omeprazole and Sodium Bicarbonate (CDFR0209) Compared With Delayed‐Release Omeprazole 40 mg Alone in Healthy Adult Male Subjects
Article
作者: Cho, Doo‐Yeoun ; Kim, Hyunil ; Yang, Sung‐Won ; Kim, Kyu‐Nam ; Kwak, Seong Shin ; Kim, Young‐Sang
Abstract:
CDFR0209, a combination of an immediate‐release formulation of omeprazole 40 mg and sodium bicarbonate 1100 mg, has been developed to treat acid‐related disorders. We compared the acid inhibitory effects of CDFR0209 and delayed‐release omeprazole (omeprazole‐DR, Losec 40 mg) after repeated dosing in Helicobacter pylori–negative healthy adult male subjects. In this 2‐period crossover study, 30 subjects were randomized to CDFR0209 or omeprazole‐DR daily for 7 days. An ambulatory continuous 24‐hour intragastric pH recording was performed at baseline and on days 1 and 7 of each administration period. Integrated gastric acidity was calculated from time‐weighted average hydrogen ion concentrations at each hour of the 24‐hour record. An analysis of variance model was used to test the pharmacodynamic equivalence of CDFR0209 and omeprazole‐DR, using the natural logarithmic transformation of the percent decrease from baseline in integrated gastric acidity for the 24‐hour interval after the seventh dose of each omeprazole formulation. The geometric least‐squares mean ratios (CDFR0209/omeprazole‐DR) of the percent decrease from baseline in integrated gastric acidity was 0.98 (90%CI, 0.93–1.07). Both CDFR0209 and omeprazole‐DR are equally effective in decreasing integrated gastric acidity at steady state.
2004-01-01Drugs in R&D4区 · 医学
Omeprazole/Antacid-Powder Suspension ??? Santarus
4区 · 医学
ReviewOA
作者: &NA;
Santarus Inc. is developing an immediate-release formulation of omeprazole in combination with an antacid (sodium bicarbonate) as a powder for suspension, known as Acitreltrade mark [SAN 05] and also as Rapinex powder for oral suspension. This omeprazole powder suspension will be used to treat gastrointestinal haemorrhage, gastro-oesophageal reflux disease, heartburn and peptic ulcers. Acitreltrade mark is based on technology licensed from the University of Missouri. Santarus have also licensed technology from Tulane and North Carolina Universities relating to potential treatments for gastrointestinal (GI) diseases. Santarus has licensed exclusive, worldwide rights to patent applications covering specific combination formulations of proton pump inhibitors (PPIs) and antacids for treating various upper GI diseases and disorders. Santarus plans to license the development, distribution and marketing rights of omeprazole powder for oral suspension 20 mg outside the US, to one or more well established pharmaceutical companies. The US FDA has requested that Santarus pursue a name other than Rapinex for the product. Santarus is currently discussing potential alternative names for the product with the FDA. Santarus announced positive results in August 2003 from a phase III trial comparing oral Acitrel (Rapinex 40 mg) with intravenous cimetidine in preventing upper GI bleeding in 359 critically ill adult patients. Santarus has also completed an open-label clinical trial in 243 patients, including 97 patients with gastric ulcers, evaluating the safety of this omeprazole 40 mg powder suspension for an 8-week period. In connection with the NDA for omeprazole powder suspension 40 mg, Santarus provided notice to the NDA holder for Prilosec delayed-release capsules and related patent owners that omeprazole powder suspension 40 mg does not infringe currently listed patents for Prilosec or that those patents are invalid.
2004-01-01Drugs in R&D
Omeprazole/Antacid-Powder Suspension ??? Santarus
Review
作者: &NA;
Santarus Inc., is developing an immediate-release formulation of omeprazole in combination with an antacid (sodium bicarbonate) as a powder for suspension, known as Acitrel [SAN 05], and also as Rapinex powder for oral suspension. Acitrel is based on technology licensed from the University of Missouri. Santarus have also licensed technology from Tulane and North Carolina Universities relating to potential treatments for GI diseases. Santarus have licensed exclusive, worldwide rights to patent applications covering specific combination-formulations of proton pump inhibitors and antacids for treating various upper GI diseases and disorders. Santarus plans to license development, distribution and marketing rights of Rapinex Powder for oral suspension 20mg outside the US, to one or more well established pharmaceutical companies. The US FDA has requested that Santarus pursue a name other than Rapinex for the product. Santarus is currently discussing potential alternative names for the product with the FDA. Santarus announced positive results, in August 2003, from a phase III trial comparing oral Acitrel (Rapinex 40mg) to intravenous cimetidine in preventing upper GI bleeding in 359 critically ill adult patients. Santarus has also completed an open-label clinical trial in 243 patients, including 97 patients with gastric ulcers, evaluating the safety of Rapinex 40mg for an 8-week period. In connection with the NDA for Rapinex 40mg, Santarus provided notice to the NDA holder for Prilosec delayed-release capsules and related patent owners that Rapinex 40mg does not infringe currently listed patents for Prilosec or that those patents are invalid.
100 项与 奥美拉唑碳酸氢钠 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 良性胃溃疡 | 美国 | 2022-08-30 | |
| 上消化道出血 | 美国 | 2022-08-30 | |
| 胃灼热 | 美国 | 2009-12-01 | |
| 胃炎 | 印度 | 2008-05-17 | |
| 胃溃疡 | 美国 | 2006-02-27 | |
| 消化道出血 | 美国 | 2004-12-21 | |
| 十二指肠溃疡 | 美国 | 2004-06-15 | |
| 糜烂性食管炎 | 美国 | 2004-06-15 | |
| 胃食管反流 | 美国 | 2004-06-15 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 胃酸缺乏 | 临床3期 | - | 2008-04-01 | |
| 食管炎 | 临床1期 | 英国 | - |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 27 | 鏇願襯鏇膚餘鏇顧繭鏇(築築獵夢糧鑰餘築積糧) = 憲積憲顧製淵醖製網範 糧簾選艱獵鬱襯衊艱築 (糧築鑰夢淵廠蓋蓋鏇鑰, 0.5) 更多 | - | 2017-06-06 | |||
临床4期 | 91 | (Omeprazole/Sodium Bicarbonate AM Dose) | 觸壓鏇獵糧憲觸鏇範鏇 = 顧顧觸繭範憲壓繭淵範 糧遞餘製憲積製襯膚膚 (構糧範顧壓鬱築築窪鹽, 衊齋選憲選壓襯鹽鏇壓 ~ 廠鏇衊艱鹽製齋構艱餘) 更多 | - | 2012-09-20 | ||
(Omeprazole/Sodium Bicarbonate PM Dose) | 觸壓鏇獵糧憲觸鏇範鏇 = 艱艱齋餘鑰獵簾衊願網 糧遞餘製憲積製襯膚膚 (構糧範顧壓鬱築築窪鹽, 襯蓋襯鹽醖顧鏇衊築齋 ~ 憲鬱壓繭餘積窪衊顧衊) 更多 | ||||||
临床3期 | 60 | (Zegerid) | 簾鬱憲構糧鹹願觸齋製(鏇窪築膚願鹽鏇繭衊鬱) = 觸顧齋壓範選鬱艱艱遞 觸選蓋網製膚簾糧鹹願 (鏇遞繭觸襯餘選膚遞齋, 窪選構築製構壓窪願壓 ~ 獵獵齋壓築醖鏇膚網鏇) 更多 | - | 2010-04-30 | ||
(Prilosec) | 簾鬱憲構糧鹹願觸齋製(鏇窪築膚願鹽鏇繭衊鬱) = 齋選繭壓襯蓋築衊鹽廠 觸選蓋網製膚簾糧鹹願 (鏇遞繭觸襯餘選膚遞齋, 範壓憲餘積淵衊蓋餘蓋 ~ 衊鬱顧艱築繭觸膚積醖) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用