[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose administration design was conducted to compare the differences in the absorption extent and absorption rate of cloperidone hydrochloride tablets under postprandial administration conditions in healthy Chinese people, as well as the safety of cloperidone hydrochloride tablets.

采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较餐后给药条件下，地奥集团成都药业股份有限公司生产的盐酸氯哌丁片（规格：10 mg）与Nipro ES Pharma Co.,Ltd.的盐酸氯哌丁片（商品名：HUSTAZOL®，规格：10 mg）在中国健康人群中吸收程度和吸收速度的差异，并评价地奥集团成都药业股份有限公司生产的盐酸氯哌丁片的安全性。

[Translation]

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and absorption rate between cloperidone hydrochloride tablets (specification: 10 mg) produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group and cloperidone hydrochloride tablets (trade name: HUSTAZOL®, specification: 10 mg) produced by Nipro ES Pharma Co., Ltd. in healthy Chinese people under the condition of postprandial administration, and to evaluate the safety of cloperidone hydrochloride tablets produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group.

Start Date03 Oct 2021

Sponsor / Collaborator

Chengdu Pharmaceutical Co. Ltd.

CTR20211331

/ CompletedNot Applicable

一项单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹和餐后评价盐酸氯哌丁片在中国健康人群中吸收程度和吸收速度的差异，以及盐酸氯哌丁片的安全性。

[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose administration design was conducted to compare fasting and postprandial administration to evaluate the differences in the absorption extent and absorption rate of cloperidone hydrochloride tablets in healthy Chinese people, as well as the safety of cloperidone hydrochloride tablets.

采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹和餐后给药条件下，地奥集团成都药业股份有限公司生产的盐酸氯哌丁片（规格：10mg）与Nipro ES Pharma Co.,Ltd.的盐酸氯哌丁片（商品名：HUSTAZOL®，规格：10mg）在中国健康人群中吸收程度和吸收速度的差异，并评价地奥集团成都药业股份有限公司生产的盐酸氯哌丁片的安全性。

[Translation]

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and rate between cloperidine hydrochloride tablets (specification: 10 mg) produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group and cloperidine hydrochloride tablets (trade name: HUSTAZOL®, specification: 10 mg) produced by Nipro ES Pharma Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of cloperidine hydrochloride tablets produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group.

Start Date24 Jun 2021

Sponsor / Collaborator

Chengdu Pharmaceutical Co. Ltd.

CTR20210293

/ CompletedNot Applicable

盐酸氯哌丁片随机、开放、两周期、两交叉健康人体空腹和餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of cloperidone hydrochloride tablets in healthy volunteers under fasting and fed conditions

主要目的：研究健康受试者在空腹/餐后状态下，单次口服由辽源市百康药业有限责任公司生产的盐酸氯哌丁片（受试制剂，10mg/片）和ニプロES ファーマ株式会社生产的盐酸氯哌丁片（参比制剂，10mg/片）的相对生物利用度，评价受试制剂与参比制剂间的生物等效性。次要目的：通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。

[Translation]

Primary objective: To study the relative bioavailability of cloperidine hydrochloride tablets (test preparation, 10 mg/tablet) produced by Liaoyuan Baikang Pharmaceutical Co., Ltd. and cloperidine hydrochloride tablets (reference preparation, 10 mg/tablet) produced by Nipro ES Pharmaceutical Co., Ltd. in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence between the test preparation and the reference preparation. Secondary objective: To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.

Start Date15 Mar 2021

Sponsor / Collaborator

Liaoyuan City Baikang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Cloperastine Hydrochloride

100 Translational Medicine associated with Cloperastine Hydrochloride

100 Patents (Medical) associated with Cloperastine Hydrochloride

364

Literatures (Medical) associated with Cloperastine Hydrochloride

01 Mar 2025·In Vivo

Renal Expression Levels of C5a Receptor and Autophagy-related Beclin-1 and LC3A/B Are Simultaneously Enhanced Under Immunoglobulin Treatment in a Rat Model of Sepsis

Article

Author: Esen, Figen ; Anakli, Ilkay ; Canbaz, Mert ; Ozcan, Perihan Ergin ; Koral, Gizem ; Tüzün, Erdem ; Ulusoy, Canan ; Yilmaz, Vuslat ; Polat, Özlem ; Orhun, Gunseli

BACKGROUND/AIMSepsis-induced acute kidney injury is a fatal, potentially reversible clinical condition. C5a receptor (C5aR) has been implied to play pivotal roles in both autophagy and sepsis-induced organ dysfunction. The aim of this study was to demonstrate the effects of intravenous immunoglobulin preparations on the expression of autophagy markers and investigate possible association between C5aR expression and autophagy in the kidney tissue of septic rats.MATERIALS AND METHODSSepsis was induced by cecal ligation perforation (CLP) in rats, which were divided into control, sham, CLP+saline, CLP+IgG (250 mg/kg, iv), and CLP+immunoglobulins enriched with immunoglobulin M (IgGAM) (250 mg/kg, iv) groups. Kidney samples were obtained in two sets of experiments to examine the early (1 day) and late (10 days) effects of treatment. Renal expression levels of C5aR, LC3A/B, and beclin-1 were measured using immunoblotting.RESULTSCLP did not enhance the renal expression of autophagy markers or C5aR. Contrariwise, IgG, and IgGAM administration reduced mortality caused by the CLP procedure and significantly increased C5aR, beclin-1, and LC3A/B expression levels in kidney samples of septic rats. Surviving rats had higher renal expression levels of C5aR, beclin-1, and LC3A/B than deceased rats. Expression levels of C5aR, beclin-1, and LC3A/B showed a strong correlation during the early stage of CLP-induced sepsis but not in the late stage.CONCLUSIONHuman-derived immunoglobulin preparations may ameliorate sepsis-related organ dysfunction partially through autophagy-related mechanisms. In the early stage of treatment, enhancement of autophagy in the kidney appears to be associated with C5aR expression.

18 Dec 2024·Chemosphere

Assessing hepatotoxicity induced by co-exposure to chlorpyrifos and deltamethrin in hook snout carp (Opsariichthys bidens Günther): A comprehensive analysis biochemical and molecular response analysis.

Article

Author: Wang, Yihan ; Wang, Yanhua ; Huang, Nan ; Chen, Chen ; Liu, Panpan ; Lou, Yancen ; Shao, Kan

Chlorpyrifos (CLP) and deltamethrin (DTM) are among the most widely utilized organophosphate and pyrethroid insecticides globally. Their simultaneous presence in aquatic environments poses significant threats to fish health and challenges the sustainability of aquaculture practices. Despite their prevalence, the combined toxic effects of CLP and DTM on hook snout carp (Opsariichthys bidens Günther) remain insufficiently understood. In this study, O. bidens were exposed to waterborne treatments of CLP, DTM, or their combination for 30 days, and the biochemical and molecular responses of the liver tissue were systematically assessed. Acute toxicity tests revealed that the combined exposure to CLP and DTM resulted in synergistic toxicity. Significant alterations in the activities of key enzymes, including superoxide dismutase (SOD), catalase (CAT), caspase-3 (CASP-3), and caspase-9 (CASP-9), relative to the control group, demonstrated that co-exposure induced oxidative stress in O. bidens. Additionally, the elevated transcriptional levels of immune-related genes such as cxcl-c1c, il-8, and il-1 suggested a pronounced inflammatory response triggered by the pesticide mixture. Conversely, the significantly reduced expression of p53 and esr indicated that combined exposure disrupted apoptotic regulation and endocrine system function in the fish. In summary, these findings demonstrated that co-exposure to CLP and DTM induced liver damage in O. bidens by impairing antioxidant enzyme activity, disrupting apoptosis regulation, and altering the transcriptional profiles of genes involved in immune and endocrine pathways. These results provided new insights into the physiological and molecular mechanisms of pesticide-induced hepatotoxicity in fish and offered valuable information for evaluating the ecological risks associated with pesticide mixtures in aquatic environments.

11 Dec 2024·Journal of the American Chemical Society

Hydrogen Isotope Labeling of Pharmaceuticals Via Dual Hydrogen Isotope Exchange Pathways Using CdS Quantum Dot Photocatalyst

Article

Author: Ren, Sumei ; Liu, Zhen-Fei ; Phillips, Eric M. ; Frimpong, Joseph ; Huang, Zheng ; Quainoo, Timothy ; Liu, Daohua ; Perras, Frédéric A. ; Luo, Long ; Maity, Rajendra ; Adeyemo, Moses ; Li, Jingwei ; Dungan, Otto ; Lehnherr, Dan

Isotopic labeling is a powerful technique extensively used in the pharmaceutical industry. By tracking isotope-labeled molecules, researchers gain unique and invaluable insights into the pharmacokinetics and pharmacodynamics of new drug candidates. Hydrogen isotope labeling is particularly important as hydrogen is ubiquitous in organic molecules in biological systems, and it can be introduced effectively through late-stage hydrogen isotope exchange (HIE). However, hydrogen isotope methods that simultaneously label multiple sites with varying types of C-H bonds in the different types of molecules are still lacking. Herein, we demonstrate a heterogeneous photocatalytic system using a CdS quantum dot catalyst that proceeds via a unique dual HIE pathway mechanism─one occurs in the reaction solution and the other on the catalytic surface─to address it. This unique mechanism unlocked several unique labeling capabilities, including simultaneous labeling of multiple and challenging sites such as secondary α-amino, α-ethereal, allyl, and vinyl sites, providing great versatility in practical uses for pharmaceutical labeling.

100 Deals associated with Cloperastine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Cloperastine Hydrochloride	R05DB21	DB09002

R&D Status

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Indication	Country/Location	Organization	Date
Cough	Japan	Nipro ES Pharma KK	11 Mar 2002

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