[Translation] A single-center, randomized, open-label, single-dose, two-period, crossover study to evaluate the bioequivalence of two brexpiprazole tablets (strength: 2 mg) in fasting and fed states in healthy Chinese subjects

主要目的：以哈尔滨珍宝制药有限公司生产的布瑞哌唑片（规格：2mg）作为受试制剂，以大塚製薬株式会社持证的布瑞哌唑片（商品名：Rexulti®，规格：2mg）为参比制剂，评估空腹及餐后状态下两种制剂的生物等效性。次要目的：评价受试制剂布瑞哌唑片（规格：2mg）和参比制剂布瑞哌唑片（商品名：Rexulti®，规格：2mg）在健康受试者中的安全性。

[Translation]

main purpose: The test preparation was bripipiprazole tablets (specification: 2 mg) produced by Harbin Zhenbao Pharmaceutical Co., Ltd., and bripipiprazole tablets (trade name: Rexulti®, specification: 2 mg) certified by Otsuka Manufacturing Co., Ltd. Reference preparation to evaluate the bioequivalence of two preparations in fasting and postprandial states. Secondary purpose: To evaluate the safety of the test preparation Bripipiprazole Tablets (specification: 2 mg) and the reference preparation Bripipiprazole Tablets (trade name: Rexulti®, specification: 2 mg) in healthy subjects.

Start Date26 Dec 2023

Sponsor / Collaborator

Haerbin Zhenbao Pharmacy Co. Ltd.

CTR20233628 / CompletedNot Applicable

盐酸莫西沙星片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of moxifloxacin hydrochloride tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂盐酸莫西沙星片（规格：0.4g；生产企业：哈尔滨珍宝制药有限公司）和参比制剂盐酸莫西沙星片（商品名：Avelox®（拜复乐）；规格：0.4g；生产企业：Bayer HealthCare Manufacturing.S.r.l.；持证商：Bayer Vital GmbH）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂盐酸莫西沙星片和参比制剂盐酸莫西沙星片（Avelox®）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation Moxifloxacin Hydrochloride Tablets (Specification: 0.4g; Manufacturer: Harbin Zhenbao Pharmaceutical Co., Ltd.) and the reference preparation Moxifloxacin Hydrochloride Tablets (Trade name: Avelox®; Specification: 0.4g; Manufacturer: Bayer HealthCare Manufacturing. S.r.l.; Licensee: Bayer Vital GmbH) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation Moxifloxacin Hydrochloride Tablets and the reference preparation Moxifloxacin Hydrochloride Tablets (Avelox®) in healthy Chinese subjects.

Start Date12 Dec 2023

Sponsor / Collaborator

Haerbin Zhenbao Pharmacy Co. Ltd.

CTR20230411 / CompletedNot Applicable

一项单中心、随机、开放、单剂量、两周期、两序列、交叉试验评价两种富马酸比索洛尔片（规格：5 mg）空腹和餐后状态下在中国健康人群中的生物等效性

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover study to evaluate the bioequivalence of two bisoprolol fumarate tablets (strength: 5 mg) in the fasting and fed state in healthy Chinese subjects

以哈尔滨珍宝制药有限公司生产的富马酸比索洛尔片（规格：5 mg）作为受试制剂，以Merck Serono GmbH持证的富马酸比索洛尔片（商品名：康忻®；规格：5 mg）为参比制剂，评估受试制剂和参比制剂在空腹及餐后条件下给药时的生物等效性，评价受试制剂富马酸比索洛尔片（规格：5 mg）和参比制剂富马酸比索洛尔片（商品名：康忻®，规格：5 mg）在健康受试者中的安全性。

[Translation]

Bisoprolol fumarate tablets (specification: 5 mg) produced by Harbin Zhenbao Pharmaceutical Co., Ltd. was used as the test preparation, and bisoprolol fumarate tablets (trade name: Kangxin®; specification: 5 mg) certified by Merck Serono GmbH was used as the reference preparation. The bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions was evaluated, and the safety of the test preparation bisoprolol fumarate tablets (specification: 5 mg) and the reference preparation bisoprolol fumarate tablets (trade name: Kangxin®, specification: 5 mg) in healthy subjects was evaluated.

Start Date23 Mar 2023

Sponsor / Collaborator

Haerbin Zhenbao Pharmacy Co. Ltd.

100 Clinical Results associated with Haerbin Zhenbao Pharmacy Co. Ltd.

0 Patents (Medical) associated with Haerbin Zhenbao Pharmacy Co. Ltd.

Literatures (Medical) associated with Haerbin Zhenbao Pharmacy Co. Ltd.

01 Jan 2017·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Anti-platelet adhesive effect and mechanisms of Xueshuantong capsules under flow conditions].

Article

Author: You, Yun ; Chen, Ying ; Zhang, Qian ; Ge, Yi-Meng ; Han, Shu-Xian ; Han, Bing ; Liao, Fu-Long ; Xiang, Yan-Hua

To investigate the anti-platelet adhesive effect and possible mechanisms of Xueshuantong capsule (XST) under flow conditions. Human umbilical vein endothelial cells (HUVECs) and human platelets were employed as experimental materials, and TNF-α (20 μg•L⁻¹) was used to establish vascular endothelial cell injury models. In vivo flow conditions were simulated under controlled shear stress of 0.1 Pa and 0.9 Pa by Bioflux1000 assays accordingly. Anti-platelet adhesive effects of XST at 0.3 g•L⁻¹ were dynamically monitored by microscopic time-lapse photography. Western blotting was employed to detect the VCAM-1 expression on endothelial cells, and the release of 6-keto-PGF1α and TXB2 was tested by radioimmunoassay. The results showed that XST could inhibit the platelets adhesion under both physiological and pathological flow conditions, and the inhibition rate was 15.0% and 34.1% respectively. Under pathological low shear stress or static conditions, XST could significantly inhibit endothelial cells VCAM-1 expression and TXB2 release (P<0.05). These results suggested that XST inhibited platelets adhering to injured endothelium via decreasing VCAM-1 expression and TXA2 secretion from endothelium. From the interactions among blood flow, vascular endothelium and platelets, the anti-thrombosis effects of XST were possibly related to endothelial cells protection and therefore inhibiting platelets adhesion. Under different flow conditions, the antiplatelet adhesion effect of XST was different, and the pathological low shear stress was more conducive to the efficacy of XST.

Organic & Biomolecular Chemistry

Metal- and light-free decarboxylative direct C–H alkylation of heteroarenes at room temperature

Article

Author: Gao, Yan ; Zhang, Tong-Bo ; Lu, Shi-Chao ; Li, Bing-Long ; Guan, Xi-Dong

This study reports a metal- and light-free decarboxylative C–H alkylation of heteroarenes at room temperature.

Frontiers in PharmacologyQ2 · MEDICINE

Anti-thrombosis Effects and Mechanisms by Xueshuantong Capsule Under Different Flow Conditions

Q2 · MEDICINE

ArticleOA

Author: Liang, Rixin ; Chen, Ying ; Zhang, Qian ; Liao, Fulong ; Ge, Yimeng ; Han, Bing ; You, Yun ; Wang, Jinyu ; Xiang, Yanhua ; Han, Shuxian ; Zhu, Xiaoxin

Xueshuantong capsule (XST) is a patented traditional Chinese medicine used for the prevention and treatment of thrombosis. The molecular mechanism of anti-thrombotic effect of XST was investigated through the cross-talk among the platelets/leukocytes, endothelial cells (ECs), and flow shear stress. The Bioflux 1000 system was used to generate two levels of shear stress conditions: 0.1 and 0.9 Pa. Bioflux Metamorph microscopic imaging system was used to analyze the adhesion cell numbers. Protein expressions were detected by western blotting and flow cytometry. The flow-cytometry results showed that under 0.1 Pa flow, XST decreased ADP induced platelets CD62p surface expression in a concentration-dependent manner. Under 0.9 Pa flow, XST at a concentration of 0.15 g⋅L^-1 reduced the platelets activation by 29.5%, and aspirin (ASA) showed no inhibitory effects. XST showed similar efficiency on monocytes adhesion both under 0.1 and 0.9 Pa flow conditions, and the inhibition rate was 30.2 and 28.3%, respectively. Under 0.9 Pa flow, the anti-adhesive effects of XST might be associated with the suppression of VE-cadherin and Cx43 in HUVECs. Blood flow not only acts as a drug transporter, but also exerts its effects to influence the pharmacodynamics of XST. Effects of XST on inhibiting platelets activation and suppressing platelets/leukocytes adhesion to injured ECs are not only concentration-dependent, but also shear stress-dependent. The mechanic forces combined with traditional Chinese medicine may be used as a precise treatment for cardiovascular diseases.

100 Deals associated with Haerbin Zhenbao Pharmacy Co. Ltd.

100 Translational Medicine associated with Haerbin Zhenbao Pharmacy Co. Ltd.

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