[Translation] A single-center, randomized, open-label, single-dose, two-drug, four-cycle, fully repeated crossover human bioequivalence study of rivaroxaban tablets in Chinese healthy subjects

主要研究目的：以植恩生物技术股份有限公司生产的利伐沙班片（规格：2.5mg）为受试制剂（T），按有关生物等效性试验的规定，以Bayer AG生产的利伐沙班片（规格：2.5mg，商品名：Xarelto®）为参比制剂（R）进行生物等效性试验。次要研究目的：观察受试制剂和参比制剂利伐沙班片在健康受试者中的安全性。

[Translation]

Main research purpose: The bioequivalence test was conducted using Rivaroxaban Tablets (specification: 2.5 mg) produced by Zhien Biotechnology Co., Ltd. as the test preparation (T) and Rivaroxaban Tablets (specification: 2.5 mg, trade name: Xarelto®) produced by Bayer AG as the reference preparation (R) according to the relevant provisions of the bioequivalence test. Secondary research purpose: Observe the safety of the test preparation and the reference preparation Rivaroxaban Tablets in healthy subjects.

Start Date08 May 2024

Sponsor / Collaborator

Chongqing Zhi'en Pharmaceutical Co., Ltd.

CTR20240902 / CompletedNot Applicable

多巴丝肼片（0.25 g）人体生物等效性研究

[Translation] Study on the bioequivalence of dopamine tablets (0.25 g) in healthy volunteers

以重庆锐恩医药有限公司研制的多巴丝肼片（规格：0.25 g）为受试制剂，以持证商为上海罗氏制药有限公司的多巴丝肼片（商品名：美多芭®，规格：0.25 g）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

The dopamine tablets (specification: 0.25 g) developed by Chongqing Ruien Pharmaceutical Co., Ltd. were used as the test preparation, and the dopamine tablets (trade name: Madopar®, specification: 0.25 g) produced by Shanghai Roche Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated after single administration in the fasting and postprandial states to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date08 May 2024

Sponsor / Collaborator

Chongqing Ruien Pharmaceutical Co., Ltd.

CTR20240605 / CompletedNot Applicable

甲磺司特颗粒人体生物等效性试验

[Translation] Bioequivalence study of suplastat toluene granules in human body

主要研究目的：以植恩生物技术股份有限公司生产的甲磺司特颗粒（规格：1.5g：75mg）为受试制剂（T），按有关生物等效性试验的规定，以大鹏药品工业株式会社（日本）生产的甲磺司特干糖浆（规格：1.5g：75mg，商品名：IPD® Dry Syrup 5%）为参比制剂（R）进行生物等效性试验。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study purpose: Sulfolast toluene granules (specifications: 1.5g: 75mg) produced by Zhien Biotechnology Co., Ltd. were used as the test preparation (T), and according to the relevant provisions of bioequivalence tests, Sulfolast toluene dry syrup (specifications: 1.5g: 75mg, trade name: IPD® Dry Syrup 5%) produced by Taiho Pharmaceutical Co., Ltd. (Japan) was used as the reference preparation (R) for bioequivalence tests. Secondary study purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date21 Feb 2024

Sponsor / Collaborator

Chongqing Zhi'en Pharmaceutical Co., Ltd.

100 Clinical Results associated with Chongqing Zhi'en Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Chongqing Zhi'en Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Chongqing Zhi'en Pharmaceutical Co., Ltd.

18 Apr 2023·ACS omega

Synthesis, Structure Revision, and Anti-inflammatory Activity Investigation of Putative Blumeatin.

Article

Author: Wang, Lu ; Xia, Kai ; Yuan, Yue ; Wu, Xiao-Qiang ; Zhu, Jun-Jie ; Ai, Yi ; Song, Yu-Yang ; Cui, Zhen ; Zhong, Hang ; Zhang, Zheng-Ping ; Gui, Yu-Ting ; Qi, Wei-Jin ; Tang, Shu-Ai

Blumeatin, reported herein, bearing two hydroxyl groups at C3' and C5' of ring B, is isolated from the traditional Chinese medicine Blumea balsamifera. But the isolation procedure of blumeatin from plants has limitations of prolonged duration and high cost. A procedure featuring Lewis acid-catalyzed ring closure and chiral resolution via Schiff base intermediates is provided here to prepare optically pure blumeatin and its R-isomer efficiently. Furthermore, the structure revision of putative blumeatin based on a logically synthetic procedure and NMR spectroscopic analysis was conducted. The 1D and 2D NMR data analysis unambiguously confirmed our proposal that the reported blumeatin structure has been misassigned as it corresponds to sterubin, which contains two hydroxyl groups at C3' and C4' of ring B. Finally, the results of the ear-swelling test exhibited that synthetic (±)-blumeatin and (±)-sterubin had moderate anti-inflammatory activity which was less than that of (-)-sterubin.

Zhongguo Yaofang

Preliminary study on effects and mechanism of new ecdysterone derivative TAPA on reducing blood glucose

Author: Li, Hong-wei ; Zhang, Jing ; Wang, Xiao-lin ; Tan, Zheng-huai

The objective of this paper was to evaluate the effects of new ecdysterone derivative TAPA on reducing blood glucose, and to study the mechanism preliminarily based on cell study.Rats were randomly divided into normal control group, model group, TAPA-1(1 mg/kg)group, TAPA-5(5 mg/kg)group, TAPA-25(25 mg/kg)group and rosiglitazone(2 mg/kg)group with 10 rats in each group.Type 2 diabetes model was established in those groups except for normal control group.The latter 4 groups were given relevant medicines intragastrically for consecutive 28 days.Food intake, body weight, water intake and random blood glucose were determined every week; 2 h blood glucose concentration was determined following intragastric administration of glucose 5 h after last administration to calculate AUC for investigation of glucose tolerance.Insulin-resistant Hep G2 cells were established, and effects of TAPA and rosiglitazone 1*10^-5mol/L on incorporation rate of glucose in insulin-resistant HepG2 cells were evaluated by 3H-d-glucose incorporation test under the condition of 1*10^-9mol/L and 1*10^-7mol/L insulin.Islet β cell tumor cell line 3(βTC3) was randomly divided into blank control group, TAPA-I(1*10^-10mol/L) group, TAPA-II(1*10^-8mol/L) group, TAPA-III(1*10^-6mol/L)group and gliclazide(1*10^-5mol/L) group.The content of insulin in cell was determined 24 h after incubation.Compared with normal control group, food intake, body weight and water intake of medication groups had no significant change.Compared with model group, the level of blood glucose in medication group was decreased significantly at the end of administration, and glucose tolerance was also decreased(P<0.05).Hypoglycemic effect and glucose tolerance were pos. correlated with TAPA dose and administration medication.TAPA and rosiglitazone had no significant effect on the incorporation rate of glucose in HepG2 cells, but significantly improved that of insulin-resistant HepG2 cells(P<0.01).Compared with blank control group, TAPA groups did not present any great effects on the secretion of insulin in β TC3 cells, and the secretion of insulin in βTC3 cells was increased significantly in gliclazide groups(P<0.01).TAPA could decrease blood glucose in type 2 diabetes model rats and improve glucose tolerance, also increased insulin sensitivity, but did not increase insulin secretion in vitro.

100 Deals associated with Chongqing Zhi'en Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Chongqing Zhi'en Pharmaceutical Co., Ltd.

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Donepezil Hydrochloride ( AChE )	Alzheimer Disease More	Approved
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