[Translation] A randomized, open-label, single-dose, two-formulation, self-crossover bioequivalence study of dapoxetine hydrochloride tablets (60 mg) in healthy Chinese subjects under fasting and fed conditions

主要目的：按有关生物等效性试验的规定，选择Berlin-Chemie AG为持证商的盐酸达泊西汀片（商品名：Priligy®，规格：60mg）为参比制剂，对云南龙津康佑生物医药有限公司持证的受试制剂盐酸达泊西汀片（规格：60mg）进行空腹及餐后给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹及餐后给药条件下的生物等效性。次要目的：观察健康受试者口服受试制剂盐酸达泊西汀片（规格：60mg）和参比制剂盐酸达泊西汀片（商品名：Priligy®，规格：60mg）的安全性。

[Translation]

Main purpose: According to the relevant provisions of bioequivalence test, dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 60 mg) with Berlin-Chemie AG as the licensee were selected as the reference preparation, and the human bioequivalence test of the test preparation dapoxetine hydrochloride tablets (specification: 60 mg) with Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd. was conducted under fasting and postprandial administration conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose: To observe the safety of oral administration of the test preparation dapoxetine hydrochloride tablets (specification: 60 mg) and the reference preparation dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 60 mg) to healthy subjects.

Start Date26 Jun 2024

Sponsor / Collaborator

Yunnan Longjin Kangyou Biomedical Co., Ltd.

CTR20230323 / CompletedNot Applicable

依折麦布片在健康成年受试者中随机、开放、两制剂、四周期、交叉设计生物等效性研究

[Translation] A randomized, open-label, two-dose, four-period, crossover bioequivalence study of ezetimibe tablets in healthy adult subjects

本试验旨在研究单次空腹和餐后口服由云南龙津康佑生物医药有限公司提供、昆明龙津药业股份有限公司生产的依折麦布片（10 mg）的药代动力学特征；以MSD International GmbH（Singapore Branch）生产的依折麦布片（益适纯®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of ezetimibe tablets (10 mg) provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd. and produced by Kunming Longjin Pharmaceutical Co., Ltd.; using ezetimibe tablets (Esperidone®, 10 mg) produced by MSD International GmbH (Singapore Branch) as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, to evaluate the human bioequivalence of the two preparations, and to observe the safety of the two preparations in healthy subjects.

Start Date15 Feb 2023

Sponsor / Collaborator

Yunnan Longjin Kangyou Biomedical Co., Ltd.

CTR20223231 / CompletedNot Applicable

枸橼酸西地那非口崩片在健康成年男性受试者中随机、开放、两制剂、两周期、双交叉空腹状态下生物等效性研究

[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of sildenafil citrate orodisintegrating tablets in healthy adult male subjects under fasting conditions

主要研究目的研究空腹状态下单次口服受试制剂枸橼酸西地那非口崩片（规格：50 mg，由昆明龙津药业股份有限公司生产，云南龙津康佑生物医药有限公司提供）与枸橼酸西地那非口崩片（万艾可®，规格：50 mg；由Pfizer Limited持证，云南龙津康佑生物医药有限公司提供）在健康成年男性受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要研究目的研究受试制剂枸橼酸西地那非口崩片和参比制剂枸橼酸西地那非口崩片（万艾可®）在健康成年男性受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation sildenafil citrate orodisintegrating tablets (specification: 50 mg, produced by Kunming Longjin Pharmaceutical Co., Ltd., provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd.) and sildenafil citrate orodisintegrating tablets (Viagra®, specification: 50 mg; licensed by Pfizer Limited, provided by Yunnan Longjin Kangyou Biopharmaceutical Co., Ltd.) in healthy adult male subjects in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary study objectives To study the safety of the test preparation sildenafil citrate orodisintegrating tablets and the reference preparation sildenafil citrate orodisintegrating tablets (Viagra®) in healthy adult male subjects.

Start Date15 Dec 2022

Sponsor / Collaborator

Yunnan Longjin Kangyou Biomedical Co., Ltd.

100 Clinical Results associated with Kunming Longjin Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Kunming Longjin Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Kunming Longjin Pharmaceutical Co., Ltd.

01 Oct 2023·European Journal of Pharmacology

Scutellarin attenuates oxidative stress and neuroinflammation in cerebral ischemia/reperfusion injury through PI3K/Akt-mediated Nrf2 signaling pathways

Article

Author: Ge, Wenxiu ; Fan, Lijuan ; Gu, Shengliang ; Ding, Meng ; Xie, Xueheng ; Xing, Xiaoyan ; Meng, Xiangbao ; Wang, Zhen ; Sun, Xiaobo ; Zhang, Wei ; Wang, Fan

Cerebral ischemia/reperfusion injury (CIRI) seriously threatens human life and health. Scutellarin (Scu) exhibits neuroprotective effects, but little is known about its underlying mechanism. Therefore, we explored its protective effect on CIRI and the underlying mechanism. Our results demonstrated that Scu rescued HT22 cells from cytotoxicity induced by oxygen and glucose deprivation/reoxygenation (OGD/R). Scu also showed antioxidant activity by promoting nuclear factor erythroid 2-related factor 2 (Nrf2) nuclear translocation, upregulating heme oxygenase-1 (HO-1) expression, increasing superoxide dismutase (SOD) activity, and inhibiting reactive oxygen species (ROS) generation in vitro. Additionally, Scu reduced nuclear factor-kappa B (NF-κB) activity and the levels of pro-inflammatory factors. Interestingly, these effects were abolished by Nrf2 inhibition. Furthermore, Scu reduced infarct volume and blood-brain barrier (BBB) permeability, improved sensorimotor functions and depressive behaviors, and alleviated oxidative stress and neuroinflammation in rats subjected to middle cerebral artery occlusion/reperfusion (MCAO/R). Mechanistically, Scu-induced Nrf2 nuclear accumulation and inactivation of NF-κB were accompanied by an enhanced level of phosphorylated protein kinase B (p-AKT) both in vitro and in vivo. Pharmacologically inhibiting the phosphatidylinositol-3-kinase/protein kinase B (PI3K/AKT) pathway blocked Scu-induced Nrf2 nuclear translocation and inactivation of NF-κB, as well as its antioxidant and anti-inflammatory activities. In summary, these results suggest that Scu exhibits antioxidant, anti-inflammatory, and neuroprotective effects in CIRI through Nrf2 activation mediated by the PI3K/Akt pathway.

01 Jul 2018·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Structural identification of related substances in Breviscapine by UPLC-QTOF-MS].

Article

Author: Wang, Xiao-Mei ; Chen, Liang-Mian ; Liu, Yuan ; Zhao, Meng ; Gao, Hui-Min ; Liu, Xiao-Qian ; Zhang, Wei ; Wang, Zhi-Min ; Wang, Peng-Fei

To systematically identify the related substances in the original materials of breviscapine injection, 18 batches of samples collected from different pharmaceutical companies, its ethanol extract and breviscapine mother liquor concentrate were analyzed by high performance liquid chromatography (HPLC), and their structures were identified by ultra performance liquid chromatography and quadruple/time-of-flight mass spectrometry (UPLC-QTOF-MS). Under the selected chromatographic conditions, scutellarin and related substances have good resolution and 13 related substances were observed. Based on the molecular weight and fragmentation patterns obtained by UPLC-QTOF-MS as well as reference substances, their structures were elucidated as 6-hydroxyapigenin-6-O-glucosyl-7-O-glucuronide (1), 5,7,8,3',4',5'-hexahydroxyflavone-7-O-glucuronide (2), 5,6,7,3',4'-pentahydroxyflavone-7-O-glucuronide（3）and its isomer (4), patuletin-3-O-glucuronide (5), methoxylscutellarin (6), apigenin 7-O-glucuronide (7), isorhamnetin 7-O-glucuronide (8), diosmetin 7-O-glucuronide (9), scutellarein (10), scutellarin methyl ester (11), scutellarin ethyl ester (12), and apigenin (13). This study has clarified related substances in the original materials of breviscapine injection, providing references for the improvement of quality control for breviscapine drug material and its preparations.

01 Jun 2017·GigaScienceQ2 · BIOLOGY

Hybrid de novo genome assembly of the Chinese herbal fleabane Erigeron breviscapus

Q2 · BIOLOGY

ArticleOA

Author: Dong, Yang ; Li, Yahe ; Zhang, Jing ; Wang, Xiao ; Yang, Shengchao ; Zhang, Guanghui ; Yang, Jing ; Chen, Wei ; Liu, Hui

BackgroundThe plants in the Erigeron genus of the Compositae (Asteraceae) family are commonly called fleabanes, possibly due to the belief that certain chemicals in these plants repel fleas. In the traditional Chinese medicine, Erigeron breviscapus , which is native to China, was widely used in the treatment of cerebrovascular disease. A handful of bioactive compounds, including scutellarin, 3,5-dicaffeoylquinic acid, and 3,4-dicaffeoylquinic acid, have been isolated from the plant. With the purpose of finding novel medicinal compounds and understanding their biosynthetic pathways, we propose to sequence the genome of E. breviscapus . We assembled the highly heterozygous E. breviscapus genome using a combination of PacBio single-molecular real-time sequencing and next-generation sequencing methods on the Illumina HiSeq platform. The final draft genome is approximately 1.2 Gb, with contig and scaffold N50 sizes of 18.8 kb and 31.5 kb, respectively. Further analyses predicted 37 504 protein-coding genes in the E. breviscapus genome and 8172 shared gene families among Compositae species. The E. breviscapus genome provides a valuable resource for the investigation of novel bioactive compounds in this Chinese herb.

100 Deals associated with Kunming Longjin Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Kunming Longjin Pharmaceutical Co., Ltd.

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Breviscapine For Injection	Angina Pectoris More	Approved
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