主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂己酮可可碱缓释片（规格：400mg，本溪匠成医药科技有限公司申办）与参比制剂己酮可可碱缓释片（Trental®，规格：400mg，Sanofi 持证），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价空腹、餐后单次口服受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of the single-dose oral (fasting/postprandial) test preparation pentoxifylline sustained-release tablets (specification: 400mg, applied for by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation pentoxifylline sustained-release tablets (Trental®, specification: 400mg, Sanofi certified) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary purpose of the study: To evaluate the safety of the test preparation and reference preparation in Chinese healthy subjects after single oral administration on an empty stomach or after a meal.

Start Date06 May 2024

Sponsor / Collaborator

Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.

CTR20240147 / CompletedNot Applicable

尼可地尔片在中国健康人群中空腹和餐后状态下口服给药的生物等效性试验

[Translation] Bioequivalence study of oral administration of nicorandil tablets in Chinese healthy subjects under fasting and fed conditions

主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂尼可地尔片（规格：5mg，本溪匠成医药科技有限公司申办）与参比制剂尼可地尔片（喜格迈®，规格：5mg，Chugai Pharmaceutical Co.，Ltd.持证），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价空腹、餐后单次口服受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main research objectives: To investigate the relative bioavailability of the single-dose oral (fasting/postprandial) test preparation Nicorandil Tablets (Specification: 5mg, applied for by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation Nicorandil Tablets (Sigma®, Specification: 5mg, licensed by Chugai Pharmaceutical Co., Ltd.) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary research objectives: To evaluate the safety of the single oral fasting and postprandial test preparations and reference preparations in healthy Chinese subjects.

Start Date18 Feb 2024

Sponsor / Collaborator

Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.

CTR20241352 / CompletedNot Applicable

健康志愿者在空腹和餐后条件下服用氢溴酸伏硫西汀片的生物等效性研究

[Translation] Bioequivalence study of vortioxetine hydrobromide tablets in healthy volunteers under fasting and fed conditions

主要研究目的以吉林四环制药有限公司生产的氢溴酸伏硫西汀片为受试制剂，按有关生物等效性试验的规定，以H.Lundbeck A/S公司生产的氢溴酸伏硫西汀片（商品名：心达悦）为参比制剂，评估两种制剂空腹和餐后给药的生物等效性。次要研究目的评价吉林四环制药有限公司生产的氢溴酸伏硫西汀片空腹和餐后单次口服给药的药代动力学（PK）特点；评价吉林四环制药有限公司生产的氢溴酸伏硫西汀片的安全性。

[Translation]

Main study objectives: To evaluate the bioequivalence of the two preparations when administered on an empty stomach and after a meal, using vortioxetine hydrobromide tablets produced by Jilin Sihuan Pharmaceutical Co., Ltd. as the test preparation and vortioxetine hydrobromide tablets (trade name: Xindayue) produced by H.Lundbeck A/S as the reference preparation according to the relevant provisions of bioequivalence tests. Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of single oral administration of vortioxetine hydrobromide tablets produced by Jilin Sihuan Pharmaceutical Co., Ltd. on an empty stomach and after a meal; to evaluate the safety of vortioxetine hydrobromide tablets produced by Jilin Sihuan Pharmaceutical Co., Ltd.

Start Date12 Dec 2023

Sponsor / Collaborator

Jilin Sihuan Pharmaceutical Co. Ltd.

100 Clinical Results associated with Beijing Sihuan Pharmaceutical Co. Ltd.

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

Literatures (Medical) associated with Beijing Sihuan Pharmaceutical Co. Ltd.

01 Sep 2020·European Journal of PharmacologyQ3 · MEDICINE

Combination of monoammonium glycyrrhizinate and cysteine hydrochloride ameliorated lipopolysaccharide/galactosamine-induced acute liver injury through Nrf2/ARE pathway

Q3 · MEDICINE

Article

Author: Cao, Peng ; Sun, Xiaoyun ; Guo, Qingxin ; Li, Xinyu ; He, Wenbin ; Chen, Naihong ; Niu, Ziquan ; Zhang, Zhao ; Bi, Haozhi ; Li, Fangfang ; Chu, Shifeng

Combination of monoammonium glycyrrhizinate and cysteine hydrochloride (MG-CH) has been used for treatment of chronic liver damage in clinic for several years, however, the effect of MG-CH on acute liver injury (ALI) is still obscure. In this study, we aimed to investigate the effect of MG-CH on ALI induced by co-injection of lipopolysaccharide (LPS) and d-galactosamine (GalN). Our results found that MG-CH produced the optimal therapeutic effect at the ratio of 2:1, as manifested by the increased survival percentage, decreased ALT and AST level and improved hepatic pathology. Both oxidative stress and inflammation induced by LPS/GalN were attenuated by MG-CH. Mechanism study showed that MG-CH promoted the nuclear accumulation of Nrf2 and its transcriptional activity, as well as improved Nrf2-target genes' expression. It was also found that activation of Nrf2 is dependent on the MG, not CH. Blockade of Nrf2 abolished the anti-inflammatory effect of MG-CHinduced by LPS/GalN, while inhibition of NFκB showed no effect on its anti-oxidative effect, though the inhibited phosphorylation of IκB and NFκB were detected in liver. The protective effect of MG-CH against ALI was abolished in Nrf2^-/- mice. All of these results suggested that MG-CH ameliorated LPS/GalN induced ALI through Nrf2/ARE pathway.

01 Mar 2019·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

A First-in-Human Safety, Tolerability, and Pharmacokinetics Study of Benapenem in Healthy Chinese Volunteers

Q2 · MEDICINE

Article

Author: Lv, Yuan ; Xia, Ya-Hong ; Zhu, Yan ; Kang, Zi-Sheng ; Tian, Ji-Hong ; Zhao, Cai-Yun ; Wei, Min-Ji ; Liu, Meng-Ying ; Ji, Xi-Wei ; Ma, Yan ; Liu, Yan

The objective of this trial was to investigate the safety, tolerability, and pharmacokinetics (PK) of benapenem administered by single or multiple intravenous infusions in healthy Chinese volunteers. The trial was divided into 3 parts.

01 Jul 2018·Journal of Stroke and Cerebrovascular DiseasesQ4 · MEDICINE

Lipopolysaccharide Induces Subacute Cerebral Microhemorrhages with Involvement of Nitric Oxide Synthase in Rats

Q4 · MEDICINE

Article

Author: Zeng, Jing ; Huang, Yonghua ; Zhào, Hóngyi ; Liu, Zhixin ; Zhang, Weiwei

BACKGROUNDCerebral microhemorrhage (CMH) is a neuropathological term that could be easily found in cerebral amyloid angiopathy, intracerebral hemorrhages, etc. CMHs could be detected clearly in vivo by magnetic resonance imaging (MRI)-susceptibility-weighted imaging or MRI T2* scan. This terminology is now accepted in the area of neuroimaging. CMHs are quite common in elderly patients and are associated with several other neuropsychiatric disorders. The causes of CMHs are complicated, and neuroinflammation is considered as one of the well-accepted mechanical factors. This study investigated whether lipopolysaccharide (LPS)-induced CMHs occur through the regulation of nitric oxide synthase (NOS) isoforms and reveals the exact underlying mechanism of LPS-induced CMHs.METHODSOur work successfully developed a subacute model of CMHs in rats. LPS was intraperitoneally injected into rats at 0, 6, and 24 hours, which induced typical CMH features 7 days after the injection. These could be detected on the brain surface or parenchyma by hematoxylin and eosin staining and MRI.RESULTSLPS-treated rats showed significant activation of astrocytes and microglia, as well as loss of pericytes and disruption of blood-brain barrier. Meanwhile, both astrocytes and microglia were positively correlated with CMH numbers. Furthermore, the expressions of NOS isoforms were also examined, and the levels of neuronal NOS and endothelial NOS were found to be elevated.CONCLUSIONSThese results implied that the NOS isoforms might be involved in the subacute model of CMHs in rats induced by LPS.

100 Deals associated with Beijing Sihuan Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Beijing Sihuan 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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Insulin degludec/Insulin aspart (Huisheng Pharm) ( INSR )	Diabetes Mellitus, Type 2 More	Approved
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