[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of piribedil sustained-release tablets (50 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择Les Laboratoires Servier为持证商的吡贝地尔缓释片（商品名：泰舒达，规格：50mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂吡贝地尔缓释片（规格：50mg）进行空腹给药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，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂吡贝地尔缓释片（规格：50mg）和参比制剂吡贝地尔缓释片（商品名：泰舒达，规格：50mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Piribedil sustained-release tablets (trade name: Taishuda, specification: 50 mg) with Les Laboratoires Servier as the licensee were selected as the reference preparation, and the test preparation Piribedil sustained-release tablets (specification: 50 mg) produced and provided by Shijiazhuang Siyao Co., Ltd. were subjected to fasting human bioequivalence test, 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 evaluate the bioequivalence of the two preparations under fasting conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Piribedil sustained-release tablets (specification: 50 mg) and the reference preparation Piribedil sustained-release tablets (trade name: Taishuda, specification: 50 mg) in healthy subjects.

Start Date06 Sep 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242755 / CompletedNot Applicable

盐酸二甲双胍片（0.5g）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of metformin hydrochloride tablets (0.5 g) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Merck Serono Limited持证，Merck S.L.生产的盐酸二甲双胍片（商品名：Glucophage，规格：0.5g）为参比制剂，对石家庄四药有限公司生产的受试制剂盐酸二甲双胍片（规格：0.5g）进行空腹和餐后给药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，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂盐酸二甲双胍片（规格：0.5g）和参比制剂盐酸二甲双胍片（商品名：Glucophage，规格：0.5g）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, metformin hydrochloride tablets (trade name: Glucophage, specification: 0.5g) certified by Merck Serono Limited and produced by Merck S.L. were selected as the reference preparation, and the test preparation metformin hydrochloride tablets (specification: 0.5g) produced by Shijiazhuang Siyao Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, 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 evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation metformin hydrochloride tablets (specification: 0.5g) and the reference preparation metformin hydrochloride tablets (trade name: Glucophage, specification: 0.5g) in healthy subjects.

Start Date02 Sep 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242925 / Active, not recruitingNot Applicable

磷酸奥司他韦胶囊（75mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两制剂、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of oseltamivir phosphate capsules (75 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Roche Pharma（Schweiz）AG为持证商的磷酸奥司他韦胶囊（商品名：达菲/Tamiflu，规格：75mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂磷酸奥司他韦胶囊（规格：75mg）进行空腹和餐后给药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，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂磷酸奥司他韦胶囊（规格：75mg）和参比制剂磷酸奥司他韦胶囊（商品名：达菲/Tamiflu，规格：75mg）的安全性。

[Translation]

The main purpose of the study: According to the relevant provisions of the bioequivalence test, oseltamivir phosphate capsules (trade name: Tamiflu, specification: 75 mg) with Roche Pharma (Schweiz) AG as the licensee were selected as the reference preparation, and the test preparation oseltamivir phosphate capsules (specification: 75 mg) produced and provided by Shijiazhuang Siyao Co., Ltd. were subjected to fasting and postprandial human bioequivalence tests 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 evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose of the study: To observe the safety of oral administration of the test preparation oseltamivir phosphate capsules (specification: 75 mg) and the reference preparation oseltamivir phosphate capsules (trade name: Tamiflu, specification: 75 mg) by healthy volunteers.

Start Date31 Aug 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

01 Apr 2024·International Immunopharmacology

Irbesartan ameliorates diabetic nephropathy by activating the Nrf2/Keap1 pathway and suppressing NLRP3 inflammasomes in vivo and in vitro

Article

Author: Gao, Menghan ; Guo, Weiying ; Zhao, Meng ; Long, Weihong ; Li, Yuan ; Yu, Lu ; Zhang, Haifeng

OBJECTIVESDiabetic nephropathy (DN) is characterized by albuminuria and renal dysfunction caused by diabetes. At present there is no specific treatment for DN. Irbesartan (IRB) is an angiotensin receptor inhibitor indicated for the treatment of hypertension and DN. However, the underlying molecular mechanisms of IRB on DN remains obscure.METHODSRAW264.7 macrophages were incubated in RPMI-1640, cell viability was evaluated by CCK-8 assays, transcriptional level of proinflammatory cytokines and was measured by ELISA and qPCR, NLRP3 inflammasome and Nrf2/Keap1 related proteins were measured by Western blotting and immunohistochemistry. Streptozotocin (STZ)-induced diabetic male C57BL/6 mice were used to evaluate the therapeutic effect of IRB on DN. Key findings First, we found that IRB improved high glucose-induced cell inflammation by inhibiting the transcription of IL-1β and IL-18. IRB activated the Nrf2/Keap1 pathway and decreased the release of reactive oxygen species (ROS). IRB also suppressed the expression of NLRP3 and caspase-1. IRB combined with the N-acetylcysteine (NAC) significantly inhibited the activation of NLRP3 inflammasomes. Conversely, IRB combined with the Nrf2-related inhibitor ML385 enhanced NLRP3 inflammasome activation, suggesting that IRB suppressed NLRP3 inflammasome via the Nrf2 pathway. In vivo study, HE staining and immunohistochemistry analysis further showed that IRB ameliorated high glucose-induced renal injury by elevating the expression of the Nrf2/Keap1 signaling pathway and suppressing the proinflammatory cytokine and NLRP3 inflammasome activation.CONCLUSIONSOur results suggested that IRB ameliorates diabetic nephropathy by activating the Nrf2/Keap1 pathway and suppressing the NLRP3 inflammasomes in vivo and in vitro. These findings provide new therapeutic strategies of diabetic nephropathy.

01 Jan 2024·Clinical Pharmacology in Drug Development

Bioequivalence of Blonanserin Tablets Under Fasting and Fed Conditions in Healthy Chinese Subjects

Article

Author: Chen, Lulu ; Wang, Jie ; Li, Xiaohui ; Lei, Yuyan ; Huang, Lifeng ; Xia, Man ; Li, Chao ; Li, Canxia ; Chen, Weiming ; Liu, Wanying ; Yan, Yu ; Wang, Caihong ; Lu, Junli

AbstractBlonanserin is a novel oral antischizophrenic drug. Under fasting (n = 50) and fed (n = 60) conditions, this study compared the bioequivalence of the generic blonanserin tablet with the reference blonanserin tablet. In this single‐center, randomized, open‐label, 2‐period, 2‐sequence, crossover study, 110 patients were randomly given a 4‐mg dose of either the test or reference blonanserin tablet with a 14‐day washout period. Blood samples were taken before performing and up to 72 hours following. A validated high‐performance liquid chromatography‐tandem mass spectrometry technique was used to measure the levels of blonanserin in plasma. Safety was evaluated throughout the study. The study found no significant differences in the maximum observed drug concentration in the plasma (Cmax), the area under the plasma concentration‐time curve from time 0 to the last sampling time (AUC0‐t), and the area under the plasma concentration‐time curve from time 0 to infinity (AUC0‐∞) between the 2 blonanserin formulations. The 90% confidence intervals of the geometric mean ratio of the test/reference formulations for Cmax, AUC0‐t, and AUC0‐∞ were within the 80%‐125% limit. Food dramatically raised blonanserin exposure, and also significantly prolonged the lag time of absorption. No serious adverse events occurred. These results indicate that the 2 blonanserin formulations were bioequivalent and well tolerated in healthy Chinese subjects. In clinical treatment, it is necessary to consider the food effect of blonanserin.

15 Nov 2022·Aging

Inhibition of NLRP3 and Golph3 ameliorates diabetes-induced neuroinflammation in vitro and in vivo

Article

Author: Li, Yuan ; Yu, Lu ; Gao, Menghan ; Long, Weihong ; Guo, Weiying ; Zhang, Haifeng

Golgi stress has been observed in various neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. Whether Golgi stress participates in hyperglycemia-induced neuroinflammation, and how it is regulated remain unclear. First, we found that high glucose (HG) could induce dispersed Golgi apparatus (GA) in BV2 cells, which can be reversed by knockout of NLRP3. Next, we discovered that HG could promote the interaction of NLRP3 and VPS35 and then enhances the interaction of VPS35 and Golph3; knockout of NLRP3 suppressed the expression of VPS35 and Golph3; knockout of VPS35 reduced the expression of Golph3 but not NLRP3, indicating that HG induced the activation of NLRP3/VPS35/Golph3 pathway in BV2 cells. Further, we elucidated the signaling pathway that Golph3 mediated GA stress in HG condition. We used GST-pulldown and Co-IP experiments methods to show that HG promoted the interaction of Golph3 and Vimentin, knockout of Golph3 alleviated the expression of Vimentin. Knockout out of Golph3 and Vimentin both ameliorated HG induced dispersed Golgi apparatus. Collectively, our study demonstrated that HG regulates GA stress through NLRP3/VPS35/Golph3/Vimentin pathway. At last, we found that a combination of small molecular inhibitors targeting NLRP3 and Golph3 selected by molecular docking could alleviate HG-induced neuroinflammation in vitro and in vivo. Therefore, the molecular inhibitors targeting NLRP3 and Golph3 have great potential for use in the development of anti-diabetes neuroinflammatory therapies.

100 Deals associated with Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

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Drug(Targets)	Indications	Global Highest Phase

NP-01(Shijiazhuang No. 4 Pharmaceutical Co., Ltd.) ( AXL x VEGFR2 x c-Met )	Advanced Malignant Solid Neoplasm More	Phase 1
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Acetaminophen ( COX )	Moderate pain More	Pending

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