[Translation] Bioequivalence study of roxatidine acetate hydrochloride extended-release capsules in Chinese healthy volunteers after single oral administration on an empty stomach or after a meal

主要目的：研究空腹及餐后单次口服盐酸罗沙替丁醋酸酯缓释胶囊受试制剂与参比制剂后罗沙替丁在中国健康受试者体内的药代动力学行为，评价空腹及餐后口服两种制剂的生物等效性。次要目的：评价中国健康受试者单次口服盐酸罗沙替丁醋酸酯缓释胶囊受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To study the pharmacokinetic behavior of roxatidine acetate hydrochloride sustained-release capsules in healthy Chinese subjects after a single oral administration of the test and reference preparations, and to evaluate the bioequivalence of the two preparations after fasting and after meals. Secondary objective: To evaluate the safety of the test and reference preparations of roxatidine acetate hydrochloride sustained-release capsules in healthy Chinese subjects after a single oral administration.

Start Date20 Aug 2020

Sponsor / Collaborator

Beijing Sihuan Pharmaceutical Co. Ltd.

CTR20190618 / Completed

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

[Translation] Fasting/fed bioequivalence study of roxatidine acetate hydrochloride extended-release capsules in healthy volunteers

以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂与参比制剂后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性，同时评价两个制剂的安全性。

[Translation]

Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test preparation and the reference preparation in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations and the safety of the two preparations.

Start Date26 Mar 2019

Sponsor / Collaborator

Fuzhou Minhai Pharmaceutical Co. Ltd.

NCT02555852 / CompletedNot ApplicableIIT

Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis

The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication used to treat gastric conditions, increase the risk of hospitalization for community-acquired pneumonia (HCAP).
The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results from the separate sites will be combined using a statistical approach called meta-analysis to provide an overall assessment of the risk of HCAP with PPIs.

Start Date01 Sep 2011

Sponsor / Collaborator

Canadian Institutes of Health Research

100 Clinical Results associated with Roxatidine Acetate Hydrochloride

100 Translational Medicine associated with Roxatidine Acetate Hydrochloride

100 Patents (Medical) associated with Roxatidine Acetate Hydrochloride

186

Literatures (Medical) associated with Roxatidine Acetate Hydrochloride

05 Sep 2023·JAMA network open

Ranitidine Use and Incident Cancer in a Multinational Cohort.

Article

Author: Lee, Hang Lak ; Hsu, Min-Huei ; Park, Rae Woong ; Hsu, Jason C ; Pratt, Nicole ; Suchard, Marc A ; Reich, Christin G ; Nguyen, Phung-Anh ; You, Seng Chan ; Prieto-Alhambra, Daniel ; Yanover, Chen ; Shah, Nigam H ; Ko, Heejoo ; Seo, Seung In ; Posada, Jose D ; Van Zandt, Mui ; Duarte-Salles, Talita ; Hripcsak, George ; Falconer, Thomas ; Park, Chan Hyuk ; Seager, Sarah ; Kim, Yeesuk ; Shin, Woon Geon

ImportanceRanitidine, 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.ObjectiveTo examine the comparative risk of cancer associated with the use of ranitidine vs other H2RAs.Design, Setting, and ParticipantsThis 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.ExposureThe main exposure was use of ranitidine vs other H2RAs (famotidine, lafutidine, nizatidine, and roxatidine).Main Outcomes and MeasuresThe 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.ResultsAmong 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 RelevanceIn 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.

02 Jan 2023·Journal of Biomolecular Structure and Dynamics

Binding ability of roxatidine acetate and roxatidine acetate supported chitosan nanoparticles towards bovine serum albumin: characterization, spectroscopic and molecular docking studies

Article

Author: Naqvi, Saeeda ; Manea, Yahiya Kadaf ; Khan, Amjad Mumtaz ; Zubair, Swaleha ; Alahdal, Faiza A. M. ; Khan, Rizwan Hasan ; 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.

01 May 2022·Clinical Pharmacology in Drug Development

Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained‐Release Capsule in Healthy Chinese Subjects

Article

Author: Xiao, Guiying ; Zhang, Ping ; Li, Xin ; Fan, Xingming ; Yuan, Fang ; Xu, Bing ; Li, Yuan ; Tu, Shengqing

AbstractThis 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 Deals associated with Roxatidine Acetate Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01467	Roxatidine Acetate Hydrochloride	A02BA06	DB08806

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastroesophageal Reflux	CN	Chongqing Shenghuaxi Pharmaceutical Co. Ltd.	18 Mar 2004
Hyperemesis Gravidarum	CN	Chongqing Shenghuaxi Pharmaceutical Co. Ltd.	18 Mar 2004
Acute gastritis	JP	ASKA Pharmaceutical Co., Ltd.	01 Jun 1993
Chronic gastritis	JP	ASKA Pharmaceutical Co., Ltd.	01 Jun 1993
Anastomotic ulcer	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1986
Duodenal Ulcer	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1986
Esophagitis, Peptic	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1986
Stomach Ulcer	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1986
Zollinger-Ellison Syndrome	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1986

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