[Translation] Study on the bioequivalence of enzalutamide soft capsules taken orally on an empty stomach or after meals in Chinese healthy adult volunteers

主要试验目的：在健康男性受试者体内，分别在空腹和餐后条件下，以Astellas Pharma Europe B.V.持有的恩扎卢胺软胶囊（商品名：安可坦®；规格：40 mg）为参比制剂，研究山西振东制药股份有限公司研制的恩扎卢胺软胶囊（规格：40 mg；受试制剂）的药代动力学，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：观察受试制剂、参比制剂在健康男性受试者中的安全性。次要试验目的：观察受试制剂、参比制剂在健康男性受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of enzalutamide soft capsules (specification: 40 mg; test preparation) developed by Shanxi Zhendong Pharmaceutical Co., Ltd. in healthy male subjects under fasting and postprandial conditions, using enzalutamide soft capsules (trade name: Ancotan®; specification: 40 mg) owned by Astellas Pharma Europe B.V. 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 in healthy male subjects. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy male subjects.

Start Date21 Feb 2023

Sponsor / Collaborator

Shanxi Zhendong Pharmaceutical Co., Ltd.

CTR20221983 / CompletedNot Applicable

空腹及餐后口服马来酸曲美布汀片在中国成年健康志愿者中的人体生物等效性研究

[Translation] Study on the bioequivalence of fasting and fed oral trimebutine maleate tablets in Chinese healthy adult volunteers

在健康受试者体内，分别在空腹和餐后条件下，以田边三菱制药株式会社持有的马来酸曲美布汀片（商品名：Cerekinon®；规格：100 mg）为参比制剂，研究山西振东安欣生物制药有限公司研制的马来酸曲美布汀片（规格：100 mg；受试制剂）的药代动力学，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、参比制剂的安全性。

[Translation]

In healthy subjects, the pharmacokinetics of trimebutine maleate tablets (specification: 100 mg; test preparation) developed by Shanxi Zhendong Anxin Biopharmaceutical Co., Ltd. were studied under fasting and postprandial conditions, using trimebutine maleate tablets (trade name: Cerekinon®; specification: 100 mg) owned by Mitsubishi Tanabe Pharma Corporation as the reference preparation, and the bioequivalence of the test preparation and the reference preparation was evaluated. Secondary study objective: To observe the safety of oral administration of the test preparation and the reference preparation in healthy subjects.

Start Date04 Aug 2022

Sponsor / Collaborator

Shanxi Ante Bio-Pharmaceutical Co., Ltd.

CTR20221488 / CompletedNot Applicable

含胶体果胶铋胶囊四联疗法根除幽门螺杆菌（Hp）有效性和安全性的多中心、随机、双盲双模拟、阳性对照临床研究

[Translation] A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical study on the efficacy and safety of quadruple therapy containing colloidal pectin bismuth capsules in eradicating Helicobacter pylori (Hp).

采用含枸橼酸铋钾片四联疗法作为对照，评价含胶体果胶铋胶囊四联疗法根除Hp的有效性及安全性。

[Translation]

The efficacy and safety of quadruple therapy containing colloidal bismuth pectin capsules in eradicating Hp were evaluated by using quadruple therapy containing potassium citrate bismuth tablets as a control.

Start Date14 Jul 2022

Sponsor / Collaborator

Shanxi Ante Bio-Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shanxi Zhendong Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shanxi Zhendong Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Shanxi Zhendong Pharmaceutical Co., Ltd.

01 Feb 2024·Talanta

A unique phenothiazine-based fluorescent probe using benzothiazolium as a reactivity regulator for the specific detection of hypochlorite in drinking water and living organisms

Article

Author: Fang, Jie ; Li, Wei ; Seidu, Mohammed Awal ; Gao, Shihao ; Li, Xiang ; Gao, Chao ; Zhou, Hongjun

As a common disinfectant and an essential reactive oxygen species (ROS), hypochlorite (ClO^-) plays vital roles in both water treatment and cell metabolism, but its abnormal level can cause serious harm to human health. Therefore, quantifying ClO^- level in drinking water and living organisms is extremely significant. Herein, we decorated different cationic heterocycles on phenothiazine core to construct three fluorescent probes for ClO^-. According to the results, only benzothiazolium moiety reasonably adjusted the electron cloud density at sulfur atom of phenothiazine core for the specific oxidation with ClO^-, thus endowing the prepared probe PT-BT with a perfect selectivity for ClO^-. Meanwhile, PT-BT exhibited a low detection limit (38 nM) and a fast response (within 20 s) toward ClO^-. Furthermore, this probe was utilized to fabricate a ready-to-use test strip, which could quantitatively measure ClO^- level in real water samples by a portable smartphone sensing platform. Notably, PT-BT targeted mitochondria efficiently, and successfully visualized endogenous ClO^- in living cells and zebrafish larvae. Especially, PT-BT was able to monitor the dynamic change of ClO^- level in inflammatory mice. These results strongly manifested that probe PT-BT was a promising tool for detecting ClO^- in drinking water and living organisms.

01 Feb 2024·Bioorganic Chemistry

Fourteen new 2-benzylbenzofuran glycosides with cardioprotective activity from Heterosmilax yunnanensis

Article

Author: Zhang, Xiao-Wei ; Yuan, Xiang ; Lu, Kai-Zhou ; Yang, Ya-Nan ; Du, Rong-Rong ; Li, Kun ; Qin, Wen-Jie ; Zhang, Pei-Cheng ; Duan, Xiu-Mei ; Zhou, Ji-Chao

Fourteen new 2-benzylbenzofuran O-glycosides (1-13, 15) and one new key precursor, diarylacetone (14) were isolated from the roots of Heterosmilax yunnanensis Gagnep, which all have characteristic 2,3,4-O-trisubstituted benzyl. Their structures were elucidated by 1D and 2D NMR, HRESIMS, UV and IR. The isolated compounds were assessed for their cardioprotective activities and compounds 1, 3 and 6 could significantly improve cardiomyocytes viability. Moreover, the mechanistic study revealed that these three compounds could significantly decrease intracellular ROS levels and maintain mitochondrial homeostasis upon hypoxia inducement. Consequently, 1, 3 and 6 might serve as potential lead compounds to prevent myocardial ischemia.

01 Sep 2023·Phytomedicine

Compound Kushen Injection inhibits epithelial-mesenchymal transition of gastric carcinoma by regulating VCAM1 induced by the TNF signaling pathway

Article

Author: Zhang, Jingyuan ; Tan, Yingying ; Wu, Chao ; Zhou, Wei ; Wu, Jiarui ; Duan, Xiaoxia ; Huang, Zhihong ; Guo, Fengying ; Liu, Pengyun ; Lu, Shan ; You, Leiming ; Stalin, Antony ; You, Rongli ; Wu, Zhishan ; Wang, Wei

BACKGROUNDGastric carcinoma (GC) treatment needs to be developed rapidly. Compound Kushen Injection (CKI), a formula from traditional Chinese medicine, has been used clinically in combination with chemotherapy to treat GC with satisfactory results. However, the molecular mechanism by which CKI acts to cure GC is still unclear.METHODSIn the present study, in vivo and in vitro experiments were used to assess the efficacy of CKI. Using ceRNA microarray and TMT technologies, the molecular mechanism of CKI was further investigated at the transcriptional and protein levels, and a bioinformatics approach was employed to investigate and functionally validate key CKI targets in GC.RESULTSWhen combined with cisplatin (DDP), CKI significantly increased its efficacy in preventing the proliferation and metastasis of GC cells and malignant-looking tumors in mice. High-throughput sequencing data and bioinformatics analysis showed that CKI regulated the TNF signaling pathway, epithelial-mesenchymal transition (EMT), with VCAM1 as a key target. The transcription factors CEBPB, JUN, RELA, NFKB1, the EMT mesenchymal-like cell markers N-cadherin and vimentin, as well as the expression of VCAM1 and its upstream signaling driver TNF, were all downregulated by CKI. In contrast, the expression of the EMT epithelial-like cell marker E-cadherin was upregulated.CONCLUSIONCKI can effectively inhibit GC growth and metastasis, improve body's immunity, and protect normal tissues from damage. The molecular mechanism by which CKI inhibits metastasis of GC is by regulating VCAM1 induced by the TNF signaling pathway to inhibit EMT of GC. Our results provide an important clue to clarify precisely the multi-scale molecular mechanism of CKI in the treatment of GC.

100 Deals associated with Shanxi Zhendong Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shanxi Zhendong Pharmaceutical Co., Ltd.

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FuFangKuShen	Cancer Pain More	Approved
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