[Translation] A single-dose, randomized, open-label, crossover, two-period fasting and fed bioequivalence study of levamlodipine besylate tablets in healthy subjects

主要目的：以宁波大红鹰药业股份有限公司的苯磺酸左氨氯地平片（规格：5mg）为受试制剂，以辉瑞制药有限公司的苯磺酸氨氯地平片（规格：10mg）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Using levoamlodipine besylate tablets (specification: 5 mg) of Ningbo Dahongying Pharmaceutical Co., Ltd. as the test preparation and amlodipine besylate tablets (specification: 10 mg) of Pfizer Pharmaceuticals Co., Ltd. as the reference preparation, according to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy subjects was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date28 Dec 2024

Sponsor / Collaborator

Ningbo Dahongying Pharmaceutical Co. Ltd.

CTR20244144

/ RecruitingNot Applicable

健康受试者空腹和餐后单次口服布瑞哌唑片的随机、开放、单剂量、两序列、两制剂、两周期、双交叉设计的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-formulation, two-period, double-crossover bioequivalence study of a single oral dose of brexpiprazole tablets in healthy subjects after fasting or after meals

主要研究目的：研究空腹和餐后状态下单次口服受试制剂布瑞哌唑片（规格：2mg，宁波大红鹰药业股份有限公司生产）与参比制剂布瑞哌唑片（REXULTI®，规格：2mg，Otsuka Pharmaceutical Co Ltd持证）在健康受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评价健康受试者在空腹和餐后状态下，单次口服布瑞哌唑片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation brepirazole tablets (specification: 2 mg, produced by Ningbo Dahongying Pharmaceutical Co., Ltd.) and the reference preparation brepirazole tablets (REXULTI®, specification: 2 mg, licensed by Otsuka Pharmaceutical Co Ltd) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary purpose of the study is to evaluate the safety of the test preparation and reference preparation of brepirazole tablets in healthy subjects after a single oral administration in the fasting and fed state.

Start Date04 Dec 2024

Sponsor / Collaborator

Ningbo Dahongying Pharmaceutical Co. Ltd.

CTR20233897

/ CompletedNot Applicable

氨氯地平阿托伐他汀钙片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、三序列、三周期、部分重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of amlodipine and atorvastatin calcium tablets in Chinese healthy volunteers 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Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对宁波大红鹰药业股份有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））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氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））和参比制剂氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (amlodipine/atorvastatin)) of Pharmacia and Upjohn Co LLC as the licensee were selected as the reference preparation, and the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (amlodipine/atorvastatin)) provided by Ningbo Dahongying Pharmaceutical Co., Ltd. were subjected to fasting and postprandial 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 and postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) and the reference preparation amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) in healthy volunteers.

Start Date22 Dec 2023

Sponsor / Collaborator

Ningbo Dahongying Pharmaceutical Co. Ltd.

100 Clinical Results associated with Ningbo Dahongying Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Ningbo Dahongying Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Ningbo Dahongying Pharmaceutical Co. Ltd.

02 Jan 2025·Current Molecular Medicine

Benzopyrene Aggravates Nonalcoholic Liver Fatty Diseases in Female Mice Via the AHR/ERα Axis

Article

Author: Yong, Jin ; Tao, Qing ; Wu, Yongkang ; Xie, Jing ; Zhu, Xiangyu ; Tan, Lina

Objective:Nonalcoholic fatty liver disease (NAFLD) is a prevalent liver condition worldwide, and the statistics show that men have a higher incidence and prevalence than women, but its toxicological mechanism is not completely clear. This research is intended to explore the role of BaP in NAFLD and to study how the environmental pollutant BaP influences the AHR/ERα axis to mediate the progression of NAFLD.Methods:In this study, we established NAFLD models in vivo and in vitro by treating HepG2 cells with a high-fat diet and Oleic acid (OA) in C57BL/6J mice. Liver injury indexes ALT, AST, and lipid metabolism indexes TG and TC were evaluated to verify the success of modeling. Then, the model was treated with BaP, and the mRNA and protein expressions of CYP1A1, ERα, and SREBP-1c were evaluated by RT-PCR and WB, and the changes of liver fat were evaluated by HE and oil red O staining. Next, BaP was added into the cells treated with or without estradiol (E2), and the lipid metabolism in the cells was evaluated by oil red O staining, and whether the above levels of CYP1A1, ERα and SREBP-1c were changed.Results:Our results show that after exposure to BaP, ERα protein levels in mice and cells are inhibited, mRNA and protein levels of SREBP-1c are reduced, and lipid metabolism processes are obstructed. The addition of E2 can reduce the increase of SREBP-1c mRNA and protein expression induced by OA, and reduce the deposition of lipids in cells. However, BaP treatment can weaken the action of E2 and destroy the protection of E2 in cells.Conclusion:The results showed that E2 could reduce SREBP-1c mRNA and protein levels. BaP can stimulate AHR, leading to the degradation of ERα protein, reducing the binding of E2 to ERα, and aggravating the progression of NAFLD. This reveals the toxicological mechanism by which environmental pollutant BaP influences E2 to mediate NAFLD, and provides strong evidence for differences in NAFLD between the sexes.

Shandong Huagong

Detection of potential mutagenic impurity in amlodipine besylate by LC-MS

Author: Jia, Fei ; Chen, Yunxiu ; Lou, Xiaofen ; Li, Heng ; Tan, Luyang ; Song, Huihui ; Shen, Youhong

Objective: A performance liquid chromatog.-mass spectrometry (LC-MS) method was developed to determine the potential mutagenic impurity (Et 4-(2-phthalimidoethoxy)acetylacetate) residues in amlodipine besylate.Methods: The samples were dissolved in 90% acetonitrile and prepared into solution, and the solutions were then separated on Agilent Zorbax SB-C₁₈ (4.6 mm×250 mm, 5μm) reversed-phase chromatog. column using a binary solvent composed of 0.1% formic acid in water and acetonitrile as mobile phase by gradient elution.Multiple reaction monitoring was used to acquire mass spectrometric data.External standard method was adopted for quantification.Results: The good linearity was got in the range of 3.1∼229 ng/mL, correlation coefficients was more than 0.990.Limit of detection was 0.0092 ng, and limit of quantitation was 0.0305 ng.The average recoveries ranged from 96.1%∼106.6% for four spiked levels in samples, and the relative standard deviation (RSD) was less than 5%.Conclusions: The developed method was simple, efficient, selective and sensitive, which can be used for accurate quant. measurement of the potential mutagenic impurity (Et 4-(2-phthalimidoethoxy)acetylacetate) residues in amlodipine besylate.

100 Deals associated with Ningbo Dahongying Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Ningbo Dahongying Pharmaceutical Co. Ltd.

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