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 recruiting

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.

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

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

01 May 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

HH-A, a modified honokiol, protects against cerebral ischemia/reperfusion induced brain injury in rodent via Nrf2/HO-1 signaling pathways

Article

Author: Zhang, Pingping ; Liu, Ye ; Zhang, Xin ; Zhang, Yuying

Honokiol, a bioactive component found in Magnolia officinalis, has shown in protecting against ischemic stroke in animal models. However, its poor water solubility has limited its clinical applications. In this study, we introduced a hydrophilic building block on the aromatic ring of honokiol, resulting in the synthesis of four new compounds (HH-A, -B, -C and -D) with significantly improved water solubility. We then investigated the neuroprotective effects of these compounds in mouse and rat models of transient middle cerebral artery occlusion/reperfusion (tMCAO/R) brain injury. Among the compounds tested, HH-A, also known as (S)-6-((3',5-diallyl-2,4'-dihydroxy-[1,1'-biphenyl]-3-yl)amino)-6-oxohexane-1,5-diaminium chloride, showed the most promising results. HH-A was found to significantly reduced the infarct volume and brain edema in mice. It also outperformed the other three compounds and honokiol, even surpassing the effects of edaravone dexborneol. Additionally, HH-A demonstrated dose-dependent improvements in body weight, neurological deficits, and infarct volume. Further analysis in tMCAO/R rat model revealed that HH-A treatment led to significant upregulations of Nrf2 and HO-1 in the brain. HH-A also significantly reduced the expression of HNE, and exhibited anti-apoptotic effects by decreasing the expression of Bax and increasing the expression of Bcl-2. This was further supported by a decrease in the number of TUNEL positive cells. Taken together, the neuroprotective effects of HH-A may be attributed to its ability to target the Nrf2/HO-1 signaling pathway, leading to reduced oxidative stress and apoptosis in the brain. These findings suggest that HH-A has potential as a therapeutic agent for the treatment of ischemic stroke.

01 Jan 2015·International journal of clinical and experimental pathology

Inhibitory effect of isothiocyanate derivant targeting AGPS by computer-aid drug design on proliferation of glioma and hepatic carcinoma cells.

Article

Author: Li, Wen-Ming ; Zhu, Yu ; Xue, Jing ; Zhao, Meng ; Yang, Ping ; Zhang, Ling

Lipids metabolism was involved in the process of many types of tumor and alkylglycerone phosphate synthase (AGPS) was considered implicated in tumor process. Benzyl isothiocyanate (BITC) showed the inhibitory effect of tumor and AGPS activity, therefore, we screened a group of small molecular compound based on BITC by computer-aid design targeting AGPS and the results showed that the derivants could suppress the proliferation, the expression of tumor related genes such as survivin and Bcl-2, and the level of ether lipids such as lysophosphatidic acid ether (LPAe) and platelet activating factor ether (PAFe); however, the activity of caspase-3/8 was improved in glioma U87MG and hepatic carcinoma HepG2 cells in vitro.

Zhongguo Yaolixue Tongbao

Benzyl isothiocyanate induced apoptosis of human malignant glioma cell line U-87 MG and related mechanism

Author: Wu, Qi ; Li, Wen-ming ; Zhu, Yu

The paper aimed to investigate the effect of BITC (Benzyl Isothiocyanate) on the apoptosis human malignant glioma cell line U-87 MG and related mechanism.U-87 MG was dealt with BITC; MTS assay was employed to determine the effect of BITC on the proliferation of cancer cells; flow cytometry was employed to determine the apoptotic rate and alteration of intracellular ROS; Western blot assay was used to determine the protein expression of apoptosis related gene Bcl-2, Survivin, caspase-3 and caspase-8; and RT-PCR was adopted to determine the mRNA expression of Bcl-2 and Survivin.Finally, the phosphorylation of JNK and the transcriptional activity of AP-1 were determinedBITC significantly inhibited the proliferation of U-87 MG, with an IC₅₀ of 15.2 μmol·L^-1.After 10 and 20 μmol·L^-1 BITC treatment for 24h, flow cytometry showed that the apoptotic rates were 29.3% and 68.6%(P<0.05), after 2 and 5 μmol·L^-1 BITC treatment for 24h, the contents of intracellular ROS were 3.76 folds and 6.07 folds(P<0.05), resp., compared with that of control; the expressions of pro-apoptosis proteins caspase-3 and caspase-8 were upregulated, while anti-apoptosis proteins Bcl-2 and Survivin were downregulated, the mRNA expressions of Bcl-2 were 32.7% and 19.2%(P< 0.05), the mRNA expressions of Survivin were 41.3% and 22.7%(P<0.05), the phosphorylation of JNK was increased, and the transcriptional activities of AP-1 were 42.5% and 26.7%(P<0.05) compared with that of control.BITC can inhibit the proliferation of human gliomas cell line U-87 MG by inducing oxidative damage and promoting apoptosis related gene and signal pathway.

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

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

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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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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

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