[Translation] Phase III clinical trial protocol of clevidipine butyrate injection emulsion in the treatment of hypertensive emergencies and sub-emergencies (multicenter, randomized, double-blind, parallel, positive-controlled trial)

评价丁酸氯维地平注射用乳剂治疗高血压急症与亚急症患者中的有效性和安全性

[Translation]

To evaluate the efficacy and safety of clevidipine butyrate injection emulsion in the treatment of patients with hypertensive emergencies and sub-emergencies

Start Date18 Oct 2022

Sponsor / Collaborator

SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

[+1]

CTR20212564 / CompletedPhase 1

上海上药第一生化药业有限公司研制的丁酸氯维地平注射用乳剂与Chiesi USA, Inc生产的静脉注射用乳剂丁酸氯维地平（商品名：Cleviprex®）在中国健康受试者中的一项单中心、随机、开放、两周期、双交叉、单剂量静脉推注给药的生物等效性试验

[Translation] A single-center, randomized, open-label, two-period, double-crossover, single-dose intravenous push bioequivalence study of clevidipine butyrate emulsion for injection developed by Shanghai No. 1 Biochemical Pharmaceutical Co., Ltd. and clevidipine butyrate emulsion for intravenous injection (trade name: Cleviprex®) produced by Chiesi USA, Inc in healthy Chinese subjects

主要研究目的：比较上海上药第一生化药业有限公司研制的丁酸氯维地平注射用乳剂（规格：50ml:25mg，受试制剂T）与Chiesi USA, Inc生产的静脉注射用乳剂丁酸氯维地平(clevidipine butyrate，商品名Cleviprex®)（规格：50ml:25mg，参比制剂R）在健康受试者体内的药代动力学，通过单中心、随机、开放、两周期、双交叉、餐后状态下单剂量静脉推注给药，评价两种制剂的人体生物等效性。次要研究目的：观察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 compare the pharmacokinetics of clevidipine butyrate emulsion for injection (specification: 50ml:25mg, test preparation T) developed by Shanghai No. 1 Biochemical Pharmaceutical Co., Ltd. and clevidipine butyrate emulsion for intravenous injection (Cleviprex®) produced by Chiesi USA, Inc (specification: 50ml:25mg, reference preparation R) in healthy subjects, and evaluate the bioequivalence of the two preparations by single-dose intravenous push administration in a single-center, randomized, open, two-period, double-crossover, postprandial state. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date09 Nov 2021

Sponsor / Collaborator

SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

[+1]

CTR20200179 / CompletedPhase 1

丁酸氯维地平注射用乳剂在健康受试者中单次给药剂量递增的安全性及药代动力学临床研究

[Translation] Clinical study on the safety and pharmacokinetics of clevidipine butyrate emulsion for injection in healthy subjects after single dose escalation

主要目的：丁酸氯维地平注射用乳剂在健康受试者中单次静脉给药剂量递增的药代动力学特征。次要目的：通过实验室检查、临床症状、体征、不良事件/严重不良事件等，评估丁酸氯维地平注射用乳剂的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetic characteristics of clevidipine butyrate injection emulsion after single intravenous dose escalation in healthy subjects. Secondary objective: To evaluate the safety of clevidipine butyrate injection emulsion through laboratory tests, clinical symptoms, signs, adverse events/serious adverse events, etc.

Start Date03 Mar 2020

Sponsor / Collaborator

SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

Literatures (Medical) associated with SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

01 Mar 2022·Current Pharmaceutical DesignQ4 · MEDICINE

Sodium Tanshinone IIA Sulfonate Improves Adverse Ventricular Remodeling Post-MI by Reducing Myocardial Necrosis, Modulating Inflammation, and Promoting Angiogenesis

Q4 · MEDICINE

Article

Author: Zou, Yunzeng ; Ding, Jinguo ; Jiang, Hong ; Jia, Jianguo ; Yu, Peng ; Zhang, Baoli ; Xie, Shiyao ; Ge, Junbo ; Zhang, Chunyu ; Dong, Ying ; Su, Enyong ; Huang, Zhenhui

Background and Objective:Myocardial infarction (MI) leads to pathological cardiac remodeling and heart failure. Sodium tanshinone IIA sulfonate (STS) shows to possess therapeutic potential. The present study aimed to explore the potential role of STS in ventricular remodeling post-MI.Methods:Mice were randomly divided into sham, MI + normal saline (NS) and MI + STS (20.8 mg/kg/day intraperitoneally) groups. MI was established following left anterior descending artery ligation. Cardiac function was evaluated using echocardiography. Scar size and myocardial fibrosis-associated markers were detected using Masson’s trichrome staining and western blot analysis (WB). Necrosis and inflammation were assessed using H&E staining, lactate dehydrogenase (LDH) detection, ELISA, immunohistochemical staining, and WB. Furthermore, angiogenesis markers and associated proteins were detected using immunohistochemical staining and WB.Results:Mice treated with STS exhibited significant improvements in cardiac function, smaller scar size, and low expression levels of α-smooth muscle actin and collagen I and III at 28 days following surgery, compared with the NS-treated group. Moreover, treatment with STS reduced eosinophil necrosis, the infiltration of inflammatory cells, plasma levels of LDH, high mobility group protein B1, interleukin-1β and tumor necrosis factor- α, and protein expression of these cytokines at 3 days. Macrophage infiltration was also decreased in the STS group in the early phase. Additionally, CD31+ vascular density, protein levels of hypoxia-inducible factor- 1α, and vascular endothelial growth factor were elevated in the STS-treated mice at 28 days.Conclusion:STS improved pathological remodeling post-MI, and the associated therapeutic effects may be a result of a decrease in myocardial necrosis, modulation of inflammation, and an increase in angiogenesis.

Shanghai Yiyao

Study on purification and quality of trypsin

Author: Huang Zhenhui ; Wang Xin ; Wang Yawen

Objective: To prepare high-purity trypsin and investigate its quality.Methods: The manufacturing process for the production of trypsin included dissolving trypsinogen(crude extract), inactivating virus by incubation at low p H value, desalinating by ultra-filtration, trypsinogen activating, purification by affinity chromatog., eluent desalinating by ultrafiltration, virus removal by nano-film filtration and vacuum freeze-drying.Results: The prepared trypsin could reach to the standard of pharmacopeia.Conclusion: The production cycle can be shortened, the potency of trypsin and the stability of the process can be improved, the content of chymotrypsin can be reduced and the quality and safety of trypsin can be increased.

Zhongguo Yiyao Gongye Zazhi

Synthesis of vitamin K with different ratio of cis/trans isomers

Author: Zhang, Zhigang

Vitamin K₁ with different ratio of cis/trans isomers was synthesized from natural phytol via bromination with phosphorus tribromide in the presence of different content of water to get different ratio of (E/Z)-isomeric phytyl bromide, followed by condensation with cyclopentadiene-menadione adduct and retro-Diels-Alder reaction.

100 Deals associated with SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

100 Translational Medicine associated with SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

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