更新于：2024-11-08
Roxatidine Acetate Hydrochloride
盐酸罗沙替丁醋酸酯
更新于：2024-11-08
概要
基本信息
原研机构 |
非在研机构- |
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
分子式C19H29ClN2O4 |
InChIKeyFEWCTJHCXOHWNL-UHFFFAOYSA-N |
CAS号93793-83-0 |
关联
3
项与 盐酸罗沙替丁醋酸酯 相关的临床试验中国健康受试者空腹和餐后单次口服盐酸罗沙替丁醋酸酯缓释胶囊生物等效性试验
盐酸罗沙替丁醋酸酯缓释胶囊在健康受试者中空腹/餐后生物等效性试验
Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis
100 项与 盐酸罗沙替丁醋酸酯 相关的临床结果
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100 项与 盐酸罗沙替丁醋酸酯 相关的转化医学
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100 项与 盐酸罗沙替丁醋酸酯 相关的专利（医药）
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186
项与 盐酸罗沙替丁醋酸酯 相关的文献（医药）2023-09-05JAMA network open
Ranitidine Use and Incident Cancer in a Multinational Cohort.
Article
作者: Hripcsak, George ; Park, Rae Woong ; Falconer, Thomas ; Nguyen, Phung-Anh ; Duarte-Salles, Talita ; Pratt, Nicole ; Reich, Christin G ; Posada, Jose D ; Lee, Hang Lak ; Seager, Sarah ; Ko, Heejoo ; Suchard, Marc A ; Van Zandt, Mui ; Seo, Seung In ; Yanover, Chen ; Shin, Woon Geon ; Park, Chan Hyuk ; Shah, Nigam H ; Hsu, Jason C ; Hsu, Min-Huei ; Prieto-Alhambra, Daniel ; You, Seng Chan ; Kim, Yeesuk
Importance:
Ranitidine, the most widely used histamine-2 receptor antagonist (H2RA), was withdrawn because of N-nitrosodimethylamine impurity in 2020. Given the worldwide exposure to this drug, the potential risk of cancer development associated with the intake of known carcinogens is an important epidemiological concern.
Objective:
To examine the comparative risk of cancer associated with the use of ranitidine vs other H2RAs.
Design, Setting, and Participants:
This new-user active comparator international network cohort study was conducted using 3 health claims and 9 electronic health record databases from the US, the United Kingdom, Germany, Spain, France, South Korea, and Taiwan. Large-scale propensity score (PS) matching was used to minimize confounding of the observed covariates with negative control outcomes. Empirical calibration was performed to account for unobserved confounding. All databases were mapped to a common data model. Database-specific estimates were combined using random-effects meta-analysis. Participants included individuals aged at least 20 years with no history of cancer who used H2RAs for more than 30 days from January 1986 to December 2020, with a 1-year washout period. Data were analyzed from April to September 2021.
Exposure:
The main exposure was use of ranitidine vs other H2RAs (famotidine, lafutidine, nizatidine, and roxatidine).
Main Outcomes and Measures:
The primary outcome was incidence of any cancer, except nonmelanoma skin cancer. Secondary outcomes included all cancer except thyroid cancer, 16 cancer subtypes, and all-cause mortality.
Results:
Among 1 183 999 individuals in 11 databases, 909 168 individuals (mean age, 56.1 years; 507 316 [55.8%] women) were identified as new users of ranitidine, and 274 831 individuals (mean age, 58.0 years; 145 935 [53.1%] women) were identified as new users of other H2RAs. Crude incidence rates of cancer were 14.30 events per 1000 person-years (PYs) in ranitidine users and 15.03 events per 1000 PYs among other H2RA users. After PS matching, cancer risk was similar in ranitidine compared with other H2RA users (incidence, 15.92 events per 1000 PYs vs 15.65 events per 1000 PYs; calibrated meta-analytic hazard ratio, 1.04; 95% CI, 0.97-1.12). No significant associations were found between ranitidine use and any secondary outcomes after calibration.
Conclusions and Relevance:
In this cohort study, ranitidine use was not associated with an increased risk of cancer compared with the use of other H2RAs. Further research is needed on the long-term association of ranitidine with cancer development.
2023-01-02Journal of biomolecular structure & dynamics
Binding ability of roxatidine acetate and roxatidine acetate supported chitosan nanoparticles towards bovine serum albumin: characterization, spectroscopic and molecular docking studies
Article
作者: Zubair, Swaleha ; Khan, Rizwan Hasan ; Khan, Amjad Mumtaz ; Naqvi, Saeeda ; Manea, Yahiya Kadaf ; Alahdal, Faiza A. M. ; Qashqoosh, Mohsen T. A.
The RxAc drug loaded on Tween80-chitosan-TPP nanoparticles (NRxAc) has been characterized and probed by UV-Vis, PXRD, FTIR, DLS and SEM technique. The physicochemical characteristics of NRxAc have been employed and evaluated for formulation of drug, particle size, external morphology, drug content and in vitro drug release. Multi-spectroscopic (i.e. fluorescence, UV-Vis, CD spectroscopy) and molecular docking techniques were also used to study the interaction of BSA with RxAc and NRxAc. RxAc and NRxAc quenched the fluorescence emission of BSA via a static quenching mechanism. The experimental data of Fluorescence demonstrated that the binding constant of RxAc and NRxAc were found around 104 L.mol-1, which suggests moderate binding affinity with BSA via hydrophobic forces. Through the site marker displacement experiments and molecular docking, the probable binding location of RxAc and NRxAc has been suggested in subdomain IB (site III) of BSA. Altogether, the results of present study can provide an important insight and a great deal of helpful information for future design of antiulcer drugs. Hence, The RxAc-loaded chitosan nanoparticles produced might be utilized as a successful tool for developing and using antiulcer drugs.Communicated by Ramaswamy H. Sarma.
2022-05-01Clinical pharmacology in drug development
Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained‐Release Capsule in Healthy Chinese Subjects
Article
作者: Xu, Bing ; Zhang, Ping ; Xiao, Guiying ; Yuan, Fang ; Tu, Shengqing ; Li, Yuan ; Li, Xin ; Fan, Xingming
Abstract:
This study aimed to evaluate the bioequivalence between a generic roxatidine acetate hydrochloride (RAH) sustained‐release capsule and brand‐named formulation (ALTAT) under fasting and fed conditions. An open‐label, single‐center, randomized 2‐period crossover study with a 5‐day washout period was conducted. A single oral dose of 75‐mg generic RAH sustained‐release capsule (test drug) or a commercial capsule (reference drug) was given to healthy volunteers under fasting (n = 36) and fed conditions (n = 36). Blood samples were collected at baseline and during the 24 hours after dosing. The concentrations of roxatidine acetate (ROX) and bioactive metabolite roxatidine in plasma were detected using a validated high‐performance liquid chromatography–tandem mass spectrometry method. Pharmacokinetic parameters were analyzed with noncompartmental methods. As prodrug, RAH was dehydrochloric acid to ROX in body and further rapidly converted to roxatidine. Such a rapid metabolism resulted in ROX that was hardly detected in plasma. Active metabolism roxatidine was therefore used to evaluate the pharmacokinetic process. The major pharmacokinetic parameters of roxatidine including peak plasma concentration, area under the plasma concentration–time curve from time 0 to time t, and area under the plasma concentration–time curve from time 0 to infinity were similar between the 2 preparations under fasting and fed conditions. The generic RAH sustained‐release capsule is bioequivalent to the reference drug under fasting and fed conditions in healthy Chinese subjects.
100 项与 盐酸罗沙替丁醋酸酯 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 胃食管反流 | 中国 | 2004-03-18 | |
| 妊娠剧吐 | 中国 | 2004-03-18 | |
| 急性胃炎 | 日本 | 1993-06-01 | |
| 慢性胃炎 | 日本 | 1993-06-01 | |
| 吻合口溃疡 | 日本 | 1986-07-01 | |
| 十二指肠溃疡 | 日本 | 1986-07-01 | |
| 反流性食管炎 | 日本 | 1986-07-01 | |
| 胃溃疡 | 日本 | 1986-07-01 | |
| Zollinger-Ellison综合征 | 日本 | 1986-07-01 |
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