Delving into the Latest Updates on Beijing Jialin Pharmaceutical Co., Ltd. with Synapse

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Disease Domain	Count

Endocrinology and Metabolic Disease	1
Infectious Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

HMG-CoA reductase	1
5-HT3 receptor(Serotonin 3 (5-HT3) receptor)	1

本试验旨在研究单次空腹和餐后口服北京嘉林药业股份有限公司研制、生产的秋水仙碱片（0.5 mg）的药代动力学特征；以TAKATA SEIYAKUCO.,Ltd生产的秋水仙碱片（Colchicine®，0.5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to study the pharmacokinetic characteristics of colchicine tablets (0.5 mg) developed and produced by Beijing Jialin Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using colchicine tablets (Colchicine®, 0.5 mg) produced by TAKATA SEIYAKU CO., Ltd as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Start Date12 Apr 2023

Sponsor / Collaborator

Beijing Jialin Pharmaceutical Co., Ltd.

CTR20211242

/ CompletedNot Applicable

盐酸曲美他嗪片在健康受试者中空腹和餐后的单中心、单剂量、2制剂、2周期、2序列、开放、随机、交叉的平均生物等效性试验

[Translation] A single-center, single-dose, 2-formulation, 2-period, 2-sequence, open-label, randomized, crossover average bioequivalence study of trimetazidine hydrochloride tablets in healthy subjects after fasting and feeding

主要试验目的：在健康受试者体内，分别在空腹和餐后条件下，以施维雅（天津）制药有限公司生产的盐酸曲美他嗪片（商品名：万爽力®；规格：20 mg）为参比制剂，研究北京嘉林药业股份有限公司研制的盐酸曲美他嗪片（规格：20 mg）的吸收速度与吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要试验目的：观察健康受试者口服受试制剂和参比制剂的安全性。

[Translation]

The main purpose of the study is to study the absorption rate and extent of trimetazidine hydrochloride tablets (specification: 20 mg) developed by Beijing Jialin Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, using trimetazidine hydrochloride tablets (trade name: Wanshuangli®; specification: 20 mg) produced by Servier (Tianjin) Pharmaceutical Co., Ltd. as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation when taken orally in healthy subjects.

Start Date10 Jun 2021

Sponsor / Collaborator

Beijing Jialin Pharmaceutical Co., Ltd.

CTR20190489

/ Active, not recruitingNot Applicable

健康受试者空腹口服阿托伐他汀钙片2制剂3周期3序列部分重复参比制剂校正平均生物等效性试验

[Translation] A bioequivalence study of atorvastatin calcium tablets in healthy subjects after fasting oral administration in 2 preparations, 3 cycles, and 3 sequences with the reference preparation in partly repeated doses

研究受试制剂（北京嘉林药业股份有限公司生产的阿托伐他汀钙片商品名：阿乐）与参比制剂（辉瑞制药有限公司生产的阿托伐他汀钙片商品名：立普妥）的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。

[Translation]

To study the absorption rate and extent of the test preparation (Atorvastatin calcium tablets produced by Beijing Jialin Pharmaceutical Co., Ltd., trade name: Ale) and the reference preparation (Atorvastatin calcium tablets produced by Pfizer Pharmaceuticals Co., Ltd., trade name: Lipitor) and to evaluate whether the test preparation and the reference preparation are bioequivalent.

Start Date04 Mar 2019

Sponsor / Collaborator

Beijing Jialin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Beijing Jialin Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Beijing Jialin Pharmaceutical Co., Ltd.

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2

Literatures (Medical) associated with Beijing Jialin Pharmaceutical Co., Ltd.

Yaowu Fenxi Zazhi

Determination of enantiomer in ambrisentan by HPLC

Author: Zhang, Xiao-feng ; Zeng, Yu-ling ; Tian, Li-na ; Chen, Li-yun ; Xue, Kai-yu

Objective: To develop an HPLC method for the determination of enantiomer in ambrisentan.Methods: Reference substance method was used for the qual. and quant. determinationThe separation was performed on a Chiralpak AD-H column (4.6 mm × 250 mm, 5 μm) with the mobile phase of hexane-ethanol (95:5) at a flow rate of 1.0 mL·min^-1, and the detective wavelength was set at 263 nm.Results: Ambrisentan and enantiomer were effectively separated under the above conditions with the resolution higher than 8.0; the calibration curves were linear in the concentration range of 1.04-5.18 μg·mL^-1; the recoveries (n = 3) were 106.6%, 103.4%, and 103.7% resp. at low, medium and high concentrations, with the RSD of 3.0%, 1.4% and 2.2%, resp.; the test solution was basically stable within 24 h.The enantiomer contents in six batches of ambrisentan were 0.15%, 0.13%, 0.09%, not detected, 0.12% and 0.16% resp.Conclusion: The method is suitable for determination of enantiomer in ambrisentan by methodol. validation.

Yaowu Fenxi Zazhi

Determination of related substances in atorvastatin calcium by HPLC

Author: Hou, Xiao-qing ; Chen, Li-yun ; Deng, Feng-xia ; Tian, Li-na ; Zhang, Xiao-feng

A method for the determination of the related substances of atorvastatin calcium was established.An optimal HPLC method was set up.The known impurities were qualified and quantified by standard method.Other impurities were calculated by the main component self-contrasted method.A Wondasil C₁₈ column (4.6 mm×250 mm, 5 μm) was applied.The mobile phase was acetonitrile-tetrahydrofuran-ammonium acetate buffer with a gradient elution at a flow rate of 1.0 mL·min^-1 and the detection wavelength was set at 244 nm.The column temperature was 30°C, and the volume of injection was 20 μL.The resolutions between atorvastatin and adjacent impurities (impurities B and C), and between the known impurities were greater than 1.5.The limits of quantification of impurities A, B, C, D, E were 30, 40, 40, 20, 10 ng.The calibration curves of five known impurities were linear in the self-concentration range (r>0.9901, n=5).The average recovery rates (n=9) were 98.5%, 111.3%, 91.5%, 106.6%, 106.5%; RSDs were 4.8%, 4.1%, 4.7%, 7.3%, 6.4%.The method is reproducible and accurate for determination of the related substances in atorvastatin calcium according to methodol. validation.

100 Deals associated with Beijing Jialin Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Beijing Jialin Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 31 Jan 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Atorvastatin Calcium ( HMG-CoA reductase )	Hypercholesterolemia More	Approved
Indisetron Hydrochloride ( 5-HT3 receptor )	Vomiting More	Phase 2
Efonidipine Hydrochloride Ethanolate ( L-type calcium channel )	Hypertension More	Pending