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。

开始日期2021-10-03

申办/合作机构

地奥集团成都药业股份有限公司

CTR20211331 / CompletedN/A

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。

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。

开始日期2021-06-24

申办/合作机构

地奥集团成都药业股份有限公司

CTR20210293 / CompletedN/A

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

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。

开始日期2021-03-15

申办/合作机构

辽源市百康药业有限责任公司

100 项与盐酸氯哌丁相关的临床结果

登录后查看更多信息

100 项与盐酸氯哌丁相关的转化医学

登录后查看更多信息

100 项与盐酸氯哌丁相关的专利（医药）

登录后查看更多信息

项与盐酸氯哌丁相关的文献（医药）

2023-12-21·PNAS Nexus

G-protein signaling of oxytocin receptor as a potential target for cabazitaxel-resistant prostate cancer

Article

作者: Yasumizu, Yota ; Takayama, Ken-Ichi ; Suzuki, Yutaka ; Oya, Mototsugu ; Ueda, Koji ; Baba, Yuto ; Inoue, Satoshi ; Beltran, Himisha ; Hongo, Hiroshi ; Kosaka, Takeo

AbstractAlthough the treatment armamentarium for patients with metastatic prostate cancer has improved recently, treatment options after progression on cabazitaxel (CBZ) are limited. To identify the mechanisms underlying CBZ resistance and therapeutic targets, we performed single-cell RNA sequencing of circulating tumor cells (CTCs) from patients with CBZ-resistant prostate cancer. Cells were clustered based on gene expression profiles. In silico screening was used to nominate candidate drugs for overcoming CBZ resistance in castration-resistant prostate cancer. CTCs were divided into three to four clusters, reflecting intrapatient tumor heterogeneity in refractory prostate cancer. Pathway analysis revealed that clusters in two cases showed up-regulation of the oxytocin (OXT) receptor–signaling pathway. Spatial gene expression analysis of CBZ-resistant prostate cancer tissues confirmed the heterogeneous expression of OXT-signaling molecules. Cloperastine (CLO) had significant antitumor activity against CBZ-resistant prostate cancer cells. Mass spectrometric phosphoproteome analysis revealed the suppression of OXT signaling specific to CBZ-resistant models. These results support the potential of CLO as a candidate drug for overcoming CBZ-resistant prostate cancer via the inhibition of OXT signaling.

2023-01-01·Genes & Diseases

Inhibition of PRMT5 by market drugs as a novel cancer therapeutic avenue

Article

作者: Prabhu, Lakshmi ; Jin, Jiamin ; Demir, Özlem ; Nakshatri, Harikrishna ; Jiang, Guanglong ; Liu, Yunlong ; Motolani, Aishat ; Fishel, Melissa L ; Huang, Xiumei ; Sun, Steven ; Zhang, Zhong-Yin ; Amaro, Rommie E ; Lu, Tao ; Sun, Mengyao ; Kelley, Mark R ; Safa, Ahmad ; Martin, Matthew ; Chen, Lan

Market drugs, such as Food and Drug Administration (FDA) or European Medicines Agency (EMA)-approved drugs for specific indications provide opportunities for repurposing for newer therapeutics. This potentially saves resources invested in clinical trials that verify drug safety and tolerance in humans prior to alternative indication approval. Protein arginine methyltransferase 5 (PRMT5) overexpression has been linked to promoting the tumor phenotype in several cancers, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and breast cancer (BC), making PRMT5 an important target for cancer therapy. Previously, we showed that PRMT5-mediated methylation of the nuclear factor (NF)-κB, partially contributes to its constitutive activation observed in cancers. In this study, we utilized an AlphaLISA-based high-throughput screening method adapted in our lab, and identified one FDA-approved drug, Candesartan cilexetil (Can, used in hypertension treatment) and one EMA-approved drug, Cloperastine hydrochloride (Clo, used in cough treatment) that had significant PRMT5-inhibitory activity, and their anti-tumor properties were validated using cancer phenotypic assays in vitro. Furthermore, PRMT5 selective inhibition of methyltransferase activity was confirmed by reduction of both NF-κB methylation and its subsequent activation upon drug treatment. Using in silico prediction, we identified critical residues on PRMT5 targeted by these drugs that may interfere with its enzymatic activity. Finally, Clo and Can treatment have exhibited marked reduction in tumor growth in vivo. Overall, we provide basis for pursuing repurposing Clo and Can as anti-PRMT5 cancer therapies. Our study offers potential safe and fast repurposing of previously unknown PRMT5 inhibitors into clinical practice.

2022-12-01·Drugs in R&D

Pharmacokinetics, Bioequivalence and Safety of Cloperastine in Chinese Healthy Subjects Under Fasting and Postprandial Conditions

Article

作者: Zhou, Zi-Wei ; Wen, Dan-Dan ; Gao, Li-Chen ; Li, Feng-Jiao ; Luo, Hong-Yu ; Deng, Ping ; Long, Hui-Zhi ; Cheng, Yan ; Xu, Shuo-Guo

BACKGROUNDCloperastine is a pivotal antibechic widely prescribed to treat cough caused by respiratory diseases. The present trial evaluated the pharmacokinetics (PK), bioequivalence (BE) and safety effects of the generic test (T) tablet of cloperastine after single-dose administration of cloperastine, compared with the original reference (R) tablet of cloperastine.OBJECTIVEThe purpose of this trial was to compare the PK, BE and safety of a test 10 mg versus the reference 10 mg formulation of cloperastine under fasting and postprandial conditions in healthy Chinese volunteers.METHODSA single-centre, randomised, open, double-cycle, self-crossover, single oral administration Phase I trial was performed in healthy Chinese volunteers. A total of 60 subjects were enrolled in either the fasting (28 subjects) or the postprandial condition (32 subjects). Subjects randomly received a single dose of the T or R preparation (10 mg dose). Plasma concentrations of cloperastine were analysed by a validated LC-MS/MS method. The primary endpoints of the PK parameters were the area under the plasma concentration-time curve from zero to 72 h (AUC_0-72h), under the plasma concentration-time curve from zero to infinity (AUC_0-∞) and the maximal plasma concentration (C_max). The equivalence standard range (80.0-125.0%) was used to evaluate the BE of the two preparations. The safety parameter as secondary endpoint was mainly evaluated by the occurrence of adverse events (AEs).RESULTSA total of 25 and 30 subjects in the fasting and postprandial conditions completed this clinical trial, respectively. The geometric mean ratio (GMR) of the T/R for the C_max, AUC_0-72h and AUC_0-∞ were 102.1%, 103.8% and 104.0% in the fasting condition, respectively. In the postprandial condition, the GMR of the T/R for the C_max, AUC_0-72h and AUC_0-∞ were 94.2%, 98.8% and 99.0%, respectively. All the values fell within the range (80.0-125.0%). The C_max and AUC_0-72h values of the T and R preparations in fasting and postprandial conditions were not statistically significant (P > 0.05). Furthermore, no serious adverse events (SAEs) occurred during the whole trial.CONCLUSIONSThe T and R preparations were bioequivalent under both conditions. Food has no significant effect on the absorption of cloperastine. Moreover, T and R preparations were well tolerated. The trial registration number (TRN) and date of registrations were CTR20212515, 13 October 2021.

项与盐酸氯哌丁相关的新闻（医药）

2023-05-07

·米内网

4月4个1类新药，10个改良型新药报产；4个进口原研药获批，2款替尼有新适应症

摘要abstract 2023年4月CDE共承办药品注册申请1412件 4个1类新药，10个改良型新药报产仿制申请有42个品种暂无国产获批 5个存量品种首次有企业申报一致性评价 4个进口原研药获批，2款替尼获批新适应症 4个首仿品种获批，8个存量品种首家过评CDE总体承办情况据米内网中国申报进度（MED）数据库统计，2023年4月CDE共承办药品注册申请1412件。其中上市申请306件，临床申请259件，存量品种一致性评价93件。2023年1-4月CDE承办药品注册申请情况（按受理号计）创新药品种申报情况2023年4月，121个创新药品种（药品注册分类为“1”的品种）获CDE承办。其中有4个品种申请上市，化学药和治疗用生物制品各有2个。2023年4月创新药上市申请承办情况2023年4月创新药临床申请承办情况改良型新药品种申报情况2023年4月，38个改良型新药品种（药品注册分类为“2”的品种）获CDE承办，其中10个品种为上市申请。呋喹替尼胶囊、甲苯磺酸他拉唑帕利胶囊以及硫酸阿托品滴眼液均为新适应症上市申请。2023年4月改良型新药上市申请承办情况2023年4月改良型新药临床申请承办情况仿制药品种申报情况2023年4月，183个品种的仿制申请获CDE承办，阿巴帕肽注射液、阿伐替尼片、艾氟洛芬贴剂、奥拉帕利片、奥美沙坦酯氨氯地平氢氯噻嗪片、巴氯芬口服溶液、醋酸去氨加压素口服溶液、醋酸维持液(含葡萄糖)、地西泮直肠凝胶、多巴丝肼片、厄贝沙坦氨氯地平片.....等42个品种目前暂无国产仿制药获批。2023年4月仿制药品种申报情况存量品种一致性评价申报情况2023年4月，52个品种的一致性评价补充申请获CDE承办。其中阿昔莫司胶囊、二羟丙茶碱注射液、双氯芬酸钠肠溶片、注射用甲磺酸齐拉西酮、注射用盐酸兰地洛尔等5个品种为首次申报。2023年4月存量品种一致性评价申报情况其他类型申请情况2023年4月，有2个古代经典名方中药复方制剂、3个进口原研药申请上市。2023年4月其他类型品种申请情况获批情况2023年4月有一款1类创新疫苗获批上市，北京诺诚健华医药科技的奥布替尼片以及江苏恒瑞医药的马来酸吡咯替尼片有新适应症获批。此外还有4个进口原研药获批。60个仿制药获批，其中奥美拉唑碳酸氢钠胶囊(Ⅱ)(北京百奥药业)、屈螺酮炔雌醇片(Ⅱ)(浙江仙琚制药)、溴夫定片(湖南华纳大药厂)、盐酸二甲双胍缓释片(Ⅳ)(广州玻思韬控释药业)为国内首仿品种。33个存量品种有企业过评，其中阿替洛尔片(天津市中央药业)、丹曲林钠胶囊(武汉恒信源药业)、洛索洛芬钠分散片(山东裕欣药业)、尼麦角林片(昆山龙灯瑞迪制药)、碳酸氢钠注射液(石家庄四药)、替米沙坦胶囊(江西杏林白马药业)、盐酸氯哌丁片(地奥集团成都药业)、注射用盐酸多西环素(海南通用康力制药)为首家过评。2023年4月主要注册类型品种获批情况数据来源：米内网中国申报进度数据库（MED）、CDE、NMPA；相关统计字段按药品名称统计，时间截至2023年4月30日；获批品种按NMPA发布时间统计；药物作用靶点以及适应症整理自公开资料。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

一致性评价上市批准疫苗

2023-04-23

·药通社

批件大爆发！2天118个受理号获批，38个品种新获上市！

NMPA分别发布4月20日、21日药品批准证明文件送达信息，2批次共有118个受理号获批，其中6个为一致性评价受理号，分别为：西安海欣制药有限公司，醋氯芬酸片；仁和堂药业有限公司，马来酸氯苯那敏片；西南药业股份有限公司，异烟肼注射液；地奥集团成都药业股份有限公司，盐酸氯哌丁片；康芝药业股份有限公司，尼美舒利分散片；多多药业有限公司，氨酚曲马多片在20日发布的批件信息中，共有38个品种（51品规）获批上市，多个品种视同通过一致性评价，如：浙江仙琚制药的屈螺酮炔雌醇片（Ⅱ）；扬子江药业的格列吡嗪控释片；鲁南贝特制药的奥美拉唑碳酸氢钠胶囊；迪沙药业的阿哌沙班片；上海安必生制药雷贝拉唑钠肠溶片；成都苑东生物的艾司奥美拉唑镁肠溶干混悬剂；烟台鲁银药业的盐酸帕洛诺司琼注射液；天地恒一制药的瑞舒伐他汀钙片等。此外，诺诚健华的奥布替尼片获批上市，用于治疗复发/难治性边缘区淋巴瘤（MZL）患者。这是奥布替尼获批的第3项适应症，目前是中国首款且唯一获批治疗MZL适应症的BTK抑制剂。恒瑞医药的马来酸吡咯替尼片新适应症获批上市，与曲妥珠单抗和多西他赛联合，用于治疗表皮生长因子受体2（HER2）阳性、晚期阶段未接受过抗HER2治疗的复发或转移性乳腺癌患者。

上市批准一致性评价

100 项与盐酸氯哌丁相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	盐酸氯哌丁	R05DB21	DB09002

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
咳嗽	日本	Nipro ES Pharma KK	2002-03-11

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ERS2011	N/A	咳嗽	433	Peripheral anti-tussives (leodropropizine)	壓願網築襯積網鏇蓋築(蓋網鹽膚願淵衊築衊獵) = 艱衊觸齋顧鹹襯壓蓋鹹遞築範夢壓鹹觸顧觸艱 (醖觸夢築廠糧鏇網願醖 )	积极	2011-09-01
				Central anti-tussives (codeine and cloperastine)	壓願網築襯積網鏇蓋築(蓋網鹽膚願淵衊築衊獵) = 憲廠顧蓋壓獵簾艱廠觸遞築範夢壓鹹觸顧觸艱 (醖觸夢築廠糧鏇網願醖 )