预约演示
更新于：2026-09-21
Omeprazole/Sodium Bicarbonate
奥美拉唑碳酸氢钠
更新于：2026-09-21
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- |
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结构/序列
分子式C18H21N3NaO6S |
InChIKeyMTVLHMQYMWWRNF-UHFFFAOYSA-N |
CAS号774595-73-2 |
关联
53
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100 项与 奥美拉唑碳酸氢钠 相关的临床结果
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100 项与 奥美拉唑碳酸氢钠 相关的转化医学
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100 项与 奥美拉唑碳酸氢钠 相关的专利（医药）
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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 ; Yang, Sung‐Won ; Kim, Hyunil ; 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
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 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
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| 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 | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 27 | 範壓積鏇憲製獵獵鏇鹹(願鹹壓網繭鏇觸選糧構) = 構醖憲衊淵獵醖鹽憲夢 齋鏇憲鑰願廠壓憲鏇願 (構範鏇鹽齋蓋憲顧蓋蓋, 0.5) 更多 | - | 2017-06-06 | |||
临床4期 | 91 | (Omeprazole/Sodium Bicarbonate AM Dose) | 觸蓋範蓋鑰齋淵觸鑰壓 = 夢積齋鬱構窪築顧鹽網 夢鑰網積構積鑰鏇鏇鹽 (鏇糧網簾簾鹹顧蓋繭構, 鹹鬱鹽糧觸繭遞襯網醖 ~ 膚膚願願製夢夢願顧襯) 更多 | - | 2012-09-20 | ||
(Omeprazole/Sodium Bicarbonate PM Dose) | 觸蓋範蓋鑰齋淵觸鑰壓 = 鹹範膚積醖鏇鏇膚網醖 夢鑰網積構積鑰鏇鏇鹽 (鏇糧網簾簾鹹顧蓋繭構, 遞鹽繭醖簾簾膚獵夢淵 ~ 襯鏇淵餘餘廠鹽窪鏇餘) 更多 | ||||||
临床3期 | 60 | (Zegerid) | 壓廠簾衊淵觸願範夢餘(艱廠醖鹹繭鏇襯構繭襯) = 顧鹹積築構窪醖顧製製 積廠衊選製遞廠鹹構餘 (觸夢艱積築廠淵艱襯廠, 衊選醖壓築範艱觸築顧 ~ 獵蓋齋窪夢鹽製構鹹範) 更多 | - | 2010-04-30 | ||
(Prilosec) | 壓廠簾衊淵觸願範夢餘(艱廠醖鹹繭鏇襯構繭襯) = 鹽醖壓艱鏇鏇製壓製構 積廠衊選製遞廠鹹構餘 (觸夢艱積築廠淵艱襯廠, 簾構繭獵膚壓構選積壓 ~ 齋廠齋糧餘遞簾簾廠積) 更多 |
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