[Translation] A randomized, open-label, two-sequence crossover, completely replicated study to evaluate the bioequivalence of a single oral dose of edoxaban tosylate tablets in healthy adults under fasting/fed conditions

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后状态下单剂量口服嘉亨(珠海横琴)医药科技有限公司研制（河南福森药业有限公司生产）的甲苯磺酸艾多沙班片（规格：60mg）与Daiichi Sankyo Europe GmbH持有并生产的甲苯磺酸艾多沙班片（规格：60mg；商品名：里先安®）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：考察研究评价单剂量口服甲苯磺酸艾多沙班片（规格：60mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of a single oral dose of edoxaban tosylate tablets (60 mg) developed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd. (produced by Henan Fusen Pharmaceutical Co., Ltd.) and edoxaban tosylate tablets (60 mg; trade name: Lixianan®) owned and produced by Daiichi Sankyo Europe GmbH in healthy Chinese subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. Secondary objective: To investigate the safety of a single oral dose of edoxaban tosylate tablets (60 mg) in healthy Chinese subjects.

Start Date15 Aug 2024

Sponsor / Collaborator

Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

CTR20242545 / CompletedNot Applicable

中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验

[Translation] A randomized, open-label, two-sequence, four-period repeated crossover bioequivalence study of oral dydrogesterone tablets in Chinese healthy female subjects in the fasting and fed state

主要研究目的：研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，江苏和晨药业有限公司生产）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产）在中国健康女性受试者体内的药代动力学，评价两制剂生物等效性。次要研究目的：评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, produced by Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Daphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Daphaston®) in healthy Chinese female subjects after a single oral administration in the fasting and fed state.

Start Date03 Aug 2024

Sponsor / Collaborator

Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

CTR20241698 / CompletedNot Applicable

阿戈美拉汀片在健康受试者中随机、开放、两制剂、单剂量、两序列、四周期、完全重复交叉的空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of agomelatine tablets in healthy subjects under fasting and fed conditions

主要研究目的：研究空腹和餐后状态下单次口服受试制剂阿戈美拉汀片（规格：25mg，河南福森药业有限公司生产，嘉亨（珠海横琴）医药科技有限公司研制）与参比制剂阿戈美拉汀片（Valdoxan®，规格：25mg；Les Laboratoires Servier Industrie生产，Les Laboratoires Servier持证）在人体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评价中国健康受试者空腹和餐后单次口服受试制剂阿戈美拉汀片和参比制剂阿戈美拉汀片（Valdoxan®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation agomelatine tablets (specification: 25 mg, produced by Henan Fusen Pharmaceutical Co., Ltd., developed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.) and the reference preparation agomelatine tablets (Valdoxan®, specification: 25 mg; produced by Les Laboratoires Servier Industrie, certified by Les Laboratoires Servier) in humans after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary study objectives: To evaluate the safety of the test preparation agomelatine tablets and the reference preparation agomelatine tablets (Valdoxan®) after a single oral administration in Chinese healthy subjects after fasting and feeding.

Start Date23 Jun 2024

Sponsor / Collaborator

Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

0 Patents (Medical) associated with Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

Literatures (Medical) associated with Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

01 Sep 2024·Journal of Ethnopharmacology

Exploration on pharmacological mechanisms of YZP against neuropathic pain via inhibiting spinal inflammation and the rationality of its compatibility

Article

Author: Zhai, Baorong ; Cao, Zhiming ; Su, Jin ; Zhao, Chunhui ; Xu, Haiyu ; Yang, Hongjun ; Wu, Dan ; Wang, Ping ; Chen, Chengyu ; Li, Weijie ; Song, Naining ; Zhang, Yanqiong ; Guan, Jianli

ETHNOPHARMACOLOGICAL RELEVANCEYuanhu Zhitong Prescription (YZP) is a well-known traditional Chinese medicine (TCM) formula for neuropathic pain (NP) therapy with a satisfying clinical efficacy. However, the underlying pharmacological mechanism and its compatibility principle remain unclear.AIM OF THE STUDYThis study aims to investigate the analgesic and compatibility mechanisms of YZP on neuropathic pain (NP) at the gene and biological process levels.MATERIALS AND METHODSThe chronic constriction injury (CCI) rats were intragastrically administrated with extracts of YZP, YH and BZ separately, and then mechanical hypersensitivity were measured to evaluate the analgesic effects between YH and BZ before and after compatibility. Then, RNA-seq and bioinformatics analyses were performed to elucidate the potential mechanisms underlying YZP's analgesia and compatibility. Finally, the expression levels and significant differences of key genes were analyzed.RESULTSBehaviorally, both YZP and YH effectively alleviated mechanical allodynia in CCI rats, with YZP being superior to YH. In contrast, we did not observe an analgesic effect of BZ. Genetically, YZP, YH, and BZ reversed the expression levels of 52, 34, and 42 aberrant genes in the spinal cord of CCI rats, respectively. Mechanically, YZP was revealed to alleviate NP mainly by modulating the inflammatory response and neuropeptide signaling pathway, which are the dominant effective processes of YH. Interestingly, the effective targets of YZP were especially enriched in leukocyte activation and cytokine-mediated signaling pathways. Moreover, BZ was found to exert an adjunctive effect in enhancing the analgesic effect of YH by promoting skeletal muscle tissue regeneration and modulating calcium ion transport.CONCLUSIONSYH, as the monarch drug, plays a dominant role in the analgesic effect of YZP that effectively relieves NP by inhibiting the spinal inflammation and neuropeptide signaling pathway. BZ, as the minister drug, not only synergistically enhances analgesic processes of YH but also helps to alleviate the accompanying symptoms of NP. Consequently, YZP exerted a more potent analgesic effect than YH and BZ alone. In conclusion, our findings offer new insights into understanding the pharmacological mechanism and compatibility principle of YZP, which may support its clinical application in NP therapy.

01 Mar 2023·Fitoterapia

Lignans from the genus Piper L. and their pharmacological activities: An updated review

Review

Author: Li, Ling ; Li, Guangsong ; Zhou, Chanyuan ; Gong, Xiaojian ; Hu, Yujie ; Ma, Jiangxiong ; Chen, Chengyu ; Li, Xiaoqian ; Fan, Dongsheng ; Wu, Anguo ; Ruan, Jinghua

The genus Piper, a member of the Piperaceae family, comprises >2000 species, of which many are well known to possess considerable economic and medicinal values. Lignans are essential ingredients and are rich in Piper plants. Although many phytochemical studies have reported many lignans identified from Piper plants, comprehensive research has not reviewed these compounds. Hence, the present review reports on natural lignans from the genus Piper and their pharmacological activities. At least 275 lignans have been discovered from the Piper genus until October 2022, including traditional lignans, neolignans, oxyneolignans, norlignans, secolignans, and polyneolignans, especially some neolignans and norlignans with novel and complex scaffolds. In addition, these lignans have been reported to show various pharmacological activities, such as antimicrobial, anti-inflammatory, neuroprotective, antioxidative, anti-platelet aggregation, cytotoxic, anti-parasitic, CYP3A4 inhibitory activities, and so on. The current work presents an up-to-date critical review and a systematic summary of publications on lignans from the genus Piper to lay the groundwork and show better insights for further investigations.

01 Jan 2023·BioMed Research International

Mechanisms of Ganweikang Tablets against Chronic Hepatitis B: A Comprehensive Study of Network Analysis, Molecular Docking, and Chemical Profiling

Article

Author: Yu, Hua ; Cao, Z M ; Gao, J ; Zhao, Ming-Ming ; Chen, C Y ; Hu, Yuan-Jia ; Xiao, Lin-Xuan ; Xu, Jia-Qi ; Su, Shi-Bing ; Guan, J L

The hepatitis B virus (HBV) is one of the major viral infection problems worldwide in public health. The exclusive proprietary Chinese medicine Ganweikang (GWK) tablet has been marketed for years in the treatment of chronic hepatitis B (CHB). However, the pharmacodynamic material basis and underlying mechanism of GWK are not completely clear. This study is aimed at investigating the pharmacological mechanism of the GWK tablet in the treatment of CHB. The chemical ingredient information was obtained from the Traditional Chinese Medicine Database and Analysis Platform (TCMSP), Traditional Chinese Medicines Integrated Database (TCMID), and Shanghai Institute of Organic Chemistry of CAS. Ingredients and disease‐related targets were defined by a combination of differentially expressed genes from CHB transcriptome data and open‐source databases. Target‐pathway‐target (TPT) network analysis, molecular docking, and chemical composition analysis were adopted to further verify the key targets and corresponding active ingredients of GWK. Eight herbs of GWK were correlated to 330 compounds with positive oral bioavailability, and 199 correlated targets were identified. The TPT network was constructed based on the 146 enriched targets by KEGG pathway analysis, significantly associated with 95 pathways. Twenty‐five nonvolatile components and 25 volatile components in GWK were identified in UPLC‐QTOF/MS and GC‐MS chromatograms. The key active ingredients of GWK include ferulic acid, oleanolic acid, ursolic acid, tormentic acid, 11‐deoxyglycyrrhetic acid, dibenzoyl methane, anisaldehyde, wogonin, protocatechuic acid, psoralen, caffeate, dimethylcaffeic acid, vanillin, β‐amyrenyl acetate, formonentin, aristololactam IIIa, and 7‐methoxy‐2‐methyl isoflavone, associated with targets CA2, NFKB1, RELA, AKT1, JUN, CA1, CA6, IKBKG, FOS, EP300, CREB1, STAT1, MMP9, CDK2, ABCB1, and ABCG2.

100 Deals associated with Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

100 Translational Medicine associated with Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

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