[Translation] A single-center, randomized, open-label study was conducted to evaluate the bioequivalence and safety of Suxiulin 50 in healthy subjects using an imported similar product (Humalog 50) as a crossover control.

通过单中心、随机、开放、两次交叉的正常葡萄糖钳夹试验，评价甘李药业股份有限公司的产品—精蛋白锌重组赖脯胰岛素混合注射液（50R）（速秀霖50）与进口同类产品（优泌乐50），在健康受试者参与试验下的生物等效性和安全性，为中国的临床医生补充此领域空白，同时为海外药品注册提供了亚洲健康人群可参考数据。

[Translation]

Through a single-center, randomized, open, double-crossover normal glucose clamp study, the bioequivalence and safety of Ganli Pharmaceutical Co., Ltd.'s product, recombinant insulin lispro mixed injection (50R) (Suxiulin 50) and an imported similar product (Humalog 50) were evaluated with the participation of healthy subjects. This will fill the gap in this field for Chinese clinicians and provide reference data for healthy Asian populations for overseas drug registration.

Start Date-

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Insulin lispro protamine biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Translational Medicine associated with Insulin lispro protamine biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Patents (Medical) associated with Insulin lispro protamine biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

127

Literatures (Medical) associated with Insulin lispro protamine biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

15 Sep 2024·Cureus

Anaphylactic Reaction to Protamine Sulfate: A Case Report

Article

Author: David do Carmo, Ana ; Carvalho, Inês R ; Alexandre, André Rosa ; Nascimento, Margarida L ; Arruda Pereira, Ricardo

Protamine sulfate is a standard agent used to reverse heparin anticoagulation during cardiovascular procedures such as coronary artery bypass grafting (CABG). Although rare, it can be associated with severe adverse reactions. We present a case of a 68-year-old male with type 2 diabetes, who was on insulin lispro protamine and underwent elective CABG. Shortly after protamine administration to reverse heparin during extracorporeal circulation (ECC), the patient experienced anaphylactic shock, manifesting as tachycardia, hypotension, facial flushing, periorbital edema, and elevated serum tryptase levels. Despite prompt treatment with volume resuscitation, epinephrine, and corticosteroids, the patient's condition remained unstable, necessitating a second period of ECC for additional bypass grafting. The case contributes to the clinical literature by providing an illustrative example of how protamine hypersensitivity can complicate postoperative recovery, emphasizing the importance of vigilance and comprehensive management strategies in preventing and addressing such reactions.

01 Apr 2023·International Endodontic Journal

25‐Hydroxycholesterol induces odontoclastic differentiation through RANK–RANKL upregulation and NF‐κB activation in odontoblast‐like MDPC‐23 cells: An in vitro study

Article

Author: Seo, Jeong‐Yeon ; Kim, Jae‐Sung ; Oh, Ji‐Su ; Yu, Sun‐Kyoung ; Lim, HyangI ; Kim, Heung‐Joong ; Kang, Kyeong‐Rok ; Park, Joo‐Cheol ; Kim, Do Kyung

AbstractAimThe physiological effects and cellular mechanism of 25‐hydroxycholesterol (25‐HC), which is an oxysterol synthesized from cholesterol by cholesterol‐25‐hydroxylase (CH25H) expressed under inflammatory conditions, are still largely unknown during odontoclastogenesis. This study aimed to evaluate 25‐HC‐induced odontoclastogenesis and its cellular mechanisms in odontoblast‐like MDPC‐23 cells.MethodologyTo investigate 25‐HC‐induced odontoclastogenesis of MDPC‐23 cells and its cellular mechanism, haemotoxylin and eosin staining, tartrate‐resistant acid phosphatase (TRAP) staining, dentine resorption assay, zymography, reactive oxygen species (ROS) detection, immunocytochemistry, and nuclear translocation were performed. The experimental values are presented as mean ± standard deviation and were compared using analysis of variance, followed by post hoc multiple comparisons (Tukey's test) using SPSS software version 22 (IBM Corp.). A p‐value <.05 was considered statistically significant.ResultsLipopolysaccharide or receptor activator of nuclear factor‐κB ligand (RANKL) induced the synthesis of 25‐HC via the expression of CH25H in MDPC‐23 cells (p < .01). Multinucleated giant cells with morphological characteristics and TRAP activity of the odontoclast were increased by 25‐HC in MDPC‐23 cells (p < .01). Moreover, 25‐HC increased dentine resorption through the expression and activity of matrix metalloproteinases in MDPC‐23 cells. It not only increased the expression of odontoclastogenic biomarkers but also translocated cytosolic nuclear factor‐κB (NF‐κB) to the nucleus in MDPC‐23 cells. Additionally, 25‐HC not only increased the production of ROS (p < .01), expression of inflammatory mediators (p < .01), pro‐inflammatory cytokines, receptor activator of NF‐κB (RANK), and RANKL but also suppressed the expression of osteoprotegerin (OPG) in MDPC‐23 cells. In contrast, CDDO‐Me, a chemical NF‐κB inhibitor, decreased TRAP activity (p < .01) and downregulated the expression of the odontoclastogenic biomarkers, including RANK and RANKL, in MDPC‐23 cells.Conclusion25‐HC induced odontoclastogenesis by modulating the RANK–RANKL–OPG axis via NF‐κB activation in MDPC‐23 cells. Therefore, these findings provide that 25‐HC derived from cholesterol metabolism may be involved in the pathophysiological etiological factors of internal tooth resorption.

01 Aug 2022·Clinical and Experimental Pharmacology and Physiology

Expression of anti and pro‐inflammatory genes in human endothelial cells activated by 25‐hydroxycholesterol: A comparison of rivaroxaban and dabigatran

Article

Author: Woźniak, Ewelina ; Wojdan, Katarzyna ; Broncel, Marlena ; Pawlos, Agnieszka ; Gorzelak‐Pabiś, Paulina

AbstractAtherosclerosis is associated with a haemostatic imbalance characterized by excessive activation of pro‐inflammatory and pro‐coagulant pathways. Non‐vitamin K antagonists oral anticoagulant (NOACs) may reduce the incidence of cardiovascular events, cerebral ischemia, thromboembolic events and atherosclerosis. Chronic inflammation, vascular proliferation and the development of atherosclerosis is also influenced by 25‐hydroxycholesterol (25‐OHC). The aim of the study was to assess the effect of rivaroxaban and dabigatran on the messenger RNA (mRNA) expression of anti‐inflammatory cytokines transforming growth factor β (TGF‐β), interleukin (IL)‐37, IL‐35 as well as of pro‐inflammatory cytokines IL‐18 and IL‐23, in endothelial cells damaged by 25‐OHC. Human umbilical vascular endothelial cells (HUVECs) were treated with 25‐OHC (10 μg/mL), rivaroxaban (100, 500 ng/mL), dabigatran (100, 500 ng/mL), 25‐OHC + rivaroxaban, and 25‐OHC + dabigatran. The mRNA expression of TGF‐β, IL‐37, IL‐35 subunits EBI3 and p35, IL‐18, and IL‐23 was analysed using real‐time polymerase chain reaction (PCR). The results showed that 25‐OHC decreased TGF‐β and IL‐37 mRNA expression and increased EBI3, p35, IL‐18, IL‐23 mRNA expression in endothelial cell as compared to an untreated control (P < .05). Messenger RNA expression of TGF‐β and IL‐37 significantly increased following stimulation with rivaroxaban and dabigatran as compared to an untreated control (P < .01). In HUVECs pre‐treated with oxysterol, rivaroxaban and dabigatran increased mRNA expression of TGF‐β, IL‐37 and decreased mRNA expression of EBI3, p35, IL‐23 and IL‐18 as compared to 25‐OHC (P < .01). Our finding suggests that both rivaroxaban and dabigatran inhibit the inflammatory activation caused by oxysterol in vitro.

100 Deals associated with Insulin lispro protamine biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

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KEGG	Wiki	ATC	Drug Bank
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Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Gan & Lee Pharmaceuticals Co., Ltd.	09 May 2014

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