[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 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AstraZeneca AB为持证商的达格列净片（商品名：安达唐（FORXIGA），规格：10mg）为参比制剂，对山东新华制药股份有限公司提供的受试制剂达格列净片（规格：10mg）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达格列净片（规格：10mg）和参比制剂达格列净片（商品名：安达唐（FORXIGA），规格：10mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, dapagliflozin tablets (trade name: FORXIGA, specification: 10 mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10 mg) provided by Shandong Xinhua Pharmaceutical 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 dapagliflozin tablets (specification: 10 mg) and the reference preparation dapagliflozin tablets (trade name: FORXIGA, specification: 10 mg) in healthy volunteers.

Start Date25 Aug 2024

Sponsor / Collaborator

Shandong Xinhua Pharmaceutical Co., Ltd.

CTR20242287 / RecruitingPhase 2

一项评估托吡司特片治疗痛风伴高尿酸血症的多中心、随机、双盲、双模拟、阳性药平行对照的Ⅱ期临床研究

[Translation] A multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled phase II clinical study to evaluate the efficacy of topiramate tablets in the treatment of gout with hyperuricemia

主要目的：与别嘌醇片比较，评估托吡司特片160 mg、200 mg、240 mg维持剂量治疗痛风伴高尿酸血症的有效性和安全性。次要目的：与别嘌醇片比较，评估托吡司特片治疗痛风伴高尿酸血症时对肾功能的保护作用。

[Translation]

Primary objective: To evaluate the efficacy and safety of 160 mg, 200 mg, and 240 mg maintenance doses of topiramate tablets in the treatment of gout with hyperuricemia compared with allopurinol tablets. Secondary objective: To evaluate the protective effect of topiramate tablets on renal function in the treatment of gout with hyperuricemia compared with allopurinol tablets.

Start Date22 Aug 2024

Sponsor / Collaborator

Hunan Jiudian Pharmaceutical Co., Ltd.

[+1]

CTR20242532 / Active, not recruitingNot Applicable

盐酸多奈哌齐口崩片人体生物等效性研究

[Translation] Study on the bioequivalence of donepezil hydrochloride orodisintegrating tablets in healthy volunteers

本试验旨在研究健康研究参与者单次空腹和餐后口服山东淄博新达制药有限公司生产的盐酸多奈哌齐口崩片（5 mg）的药代动力学特征；以日本卫材株式会社生产的盐酸多奈哌齐口崩片（Aricept® D，5 mg）为参比制剂，比较两制剂中药动学参数Cmax和AUC0-72，评价两制剂的人体生物等效性，并观察两制剂在健康研究参与者中的安全性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of donepezil hydrochloride orodisintegrating tablets (5 mg) produced by Shandong Zibo Xinda Pharmaceutical Co., Ltd. in healthy study participants after single fasting and postprandial oral administration; using donepezil hydrochloride orodisintegrating tablets (Aricept® D, 5 mg) produced by Eisai Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations, to evaluate the bioequivalence of the two preparations in humans, and to observe the safety of the two preparations in healthy study participants.

Start Date09 Aug 2024

Sponsor / Collaborator

Shandong Zibo Xincat Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shandong Xinhua Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shandong Xinhua Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Shandong Xinhua Pharmaceutical Co., Ltd.

19 Jun 2024·Crystal Growth & Design

Structure Determination and 3D ED/MicroED-Guided Synthesis of a New (S)-Ibuprofen–l-phenylalanine Co-Crystal

Author: Ding, Jinsong ; Xu, Youwei ; Zhou, Wenhu ; Lin, Qing ; Huang, Jiaxin ; Zheng, Zhonghui

Pharmaceutical cocrystals are of interest to the pharmaceutical industry due to their novel potential for improving the physicochem. characteristics of old APIs.However, cocrystal screening and following synthetic optimization consume time and effort.A two-component crystalline phase of (S)-ibuprofen and L-phenylalanine with 2:3 stoichiometry (Ibu-Phe) is reported.High-quality Ibu-Phe cocrystal was synthesized easily by the liquid-assisted grinding (LAG) method, but some impurities remained.The crystal structure of Ibu-Phe can be solved ab initio from 3D ED/MicroED.Furthermore, a nearly pure Ibu-Phe cocrystal sample can be obtained under the guidance of stoichiometry from 3D ED/MicroED following synthesis optimization in a few attempts.

19 Apr 2024·The Journal of Organic Chemistry

Electromagnetic Mill-Promoted Palladium-Catalyzed Heck-Type Cyclization/Decarboxylative Coupling of (Z)-1-Iodo-1,6-diene with Propiolic Acids

Article

Author: Wang, Hui ; Cui, Hongyou ; Zhang, Xianqing ; Zhang, Lizhi ; Zhao, Zengdian ; Chi, Xiaochen ; Zhang, Daopeng ; Liu, Hui ; Liu, Qing

Electromagnetic mill (EMM)-promoted solid-state cascade Heck-type cyclization/decarboxylative coupling of propiolic acid with (Z)-1-iodo-1,6-diene derivate was demonstrated. The reaction was realized via palladium catalysis, which is solvent-free and involves no additional heating. The collision between ferromagnetic rods could not only be a favor to the mixing between the solid substrates and the catalyst system, but also the thermogenic action could accelerate this transformation. More importantly, this EMM strategy realized multiple bond construction under mechanochemical conditions in one pot.

01 Nov 2023·International Immunopharmacology

The bexarotene derivative OAB-14 ameliorates cognitive decline in APP/PS1 transgenic mice by suppressing microglia-mediated neuroinflammation through the PPAR-γ pathway

Article

Author: Cao, Ruo-Lin ; Chen, Guo-Liang ; Zhang, Feng ; Zheng, Zhong-Hui ; Zou, Li-Bo ; Liu, Peng ; Chi, Tian-Yan ; Ji, Xue-Fei

Neuroinflammation is believed to be a critical process involved in the pathophysiology of Alzheimer's disease (AD). In this study, we investigated the pharmacological ability of OAB-14, a small molecule compound derived from bexarotene, to reduce neuroinflammation and improve cognitive decline in an AD mouse model (in vivo) and its ability to regulate signaling pathways implicated in neuroinflammation in vitro. It was found that OAB-14 significantly improved the cognitive function of 11-month-old AD mice (APP/PS1 transgenic mice) in a dose-dependent manner. Simultaneously, OAB-14 dramatically inhibited the activation of microglia in the cerebral cortex and hippocampus of AD mice and dose-dependently downregulated the expression of nuclear factor kappa B (NF-κB) and NOD-like receptor protein 3 (NLRP3) in the cerebral cortex. At the cellular level, OAB-14 reversed the downregulation of M2 phenotypic markers, including mannose receptor C-type 1 (MRC1) and arginase 1 (ARG1), in lipopolysaccharide (LPS)- or amyloid-β protein oligomer (oAβ_1-42)-activated BV2 microglial cells and partially restored their ability to clear Aβ. However, these effects were suppressed when peroxisome proliferator-activated receptor-γ (PPAR-γ) was specifically inhibited by GW9662, a selective PPAR-γ antagonist. These results suggested that OAB-14 could regulate microglial polarization by regulating PPAR-γ signaling, thereby mitigating neuroinflammation and improving cognitive function in AD mice.

News (Medical) associated with Shandong Xinhua Pharmaceutical Co., Ltd.

03 Jun 2021

·www.globenewswire.com

Global Ibuprofen Market, By Product Type, By Route of

New York, June 03, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Ibuprofen Market, By Product Type, By Route of Administration, By Application, By Age Group, By Source, By End User, By Distribution Channel, By Region, Competition Forecast & Opportunities, 2026" - The global ibuprofen market is expected to grow at a steady rate during the forecast period with a CAGR of 5.67% in value terms to reach USD6945.36 million by 2026. The global ibuprofen market is driven by rise in pharmaceutical and biopharmaceutical production. Moreover, rising prevalence of chronic diseases coupled with easy availability of ibuprofen across the globe is positively impacting the growth of market during the forecast period. The major drivers of the market include rise in sports injury, easy availability, cost effective and intensifying chronic diseases are going to drive the global ibuprofen market in the forecast period.The global ibuprofen market is segmented based on product type, route of administration, application, age group, source, end user, distribution channel, company, and region.Based on route of administration, the market can be categorized into oral v/s intravenous.Out of which, oral route of administration segment dominated the market in 2020 and is expected to maintain its leading position in the market during the forecast period as well.Intravenous route for ibuprofen administration is favored for the management of post-operative and acute pain.The distribution channel segment is divided into offline and online, the offline segment is dominating the market currently, and due to emergence of COVID-19, the online market witnessed a significant growth in 2020.By source, the segment is segregated into contract manufacturing organizations (CMO) and in-house, out of which CMO segment is expected to dominate the market in the forecast period.End user segment is further segregated into hospitals, clinics and other.The hospital segment is dominating the global ibuprofen market to a significant extent.Global ibuprofen market is divided into 5 major regions that are North America, Europe, Asia Pacific, South America and Middle East and Africa. North America is dominating the market in the current period and in the forecast period too whereas, Asia Pacific is leading the market in the forecast period due to increase in geriatric population and elevation in inflammatory diseases.BASF SE, IOL Chemicals & Pharmaceuticals Ltd., Mallinckrodt plc, Lupin Pharmaceuticals, Inc., Cumberland Pharmaceuticals Inc., Shandong Xinhua Pharmaceutical Company Limited, Hubei Biocause Phamaceutical Co., Ltd., Perrigo Company PLC, Strides Pharma Science Limited, Amneal Pharmaceuticals, Inc., Pfizer Inc., Johnson & Johnson, Teligent, Inc., Solara Active Pharma Sciences Ltd., Abbott Laboratories Ltd. among others are the leading companies operating in the market. Major companies are developing advanced technologies and launching new products to stay competitive in the market. Other competitive Go-To-Market strategies include mergers & acquisitions, partnership, agreements, product launches and new developments, which have been adopted by the major to expand their geographic reach and to increase their customer bases.Years considered for this report:Historical Years: 2016-2019Base Year: 2020Estimated Year: 2021Forecast Period: 2022–2026Objective of the Study:• To analyze the historical growth in the market size of global ibuprofen market from 2016 to 2020.• To estimate and forecast the market size of global ibuprofen market from 2021 to 2026 and growth rate until 2026.• To classify and forecast global Ibuprofen market based on product type, route of administration, application, end user, age group, source, company and regional distribution.• To identify dominant region or segment in the global ibuprofen market.• To identify drivers and challenges for global ibuprofen market.• To examine competitive developments such as expansions, new product launches, mergers & acquisitions, etc., in global ibuprofen market.• To conduct pricing analysis for global ibuprofen market.• To identify and analyze the profile of leading players operating in global ibuprofen market.• To identify key sustainable strategies adopted by market players in global ibuprofen market.The analyst performed both primary as well as exhaustive secondary research for this study.Initially, the analyst sourced a list of manufacturers across the globe.Subsequently, the analyst conducted primary research surveys with the identified companies.While interviewing, the respondents were also enquired about their competitors.Through this technique, the analyst could include companies which could not be identified due to the limitations of secondary research. The analyst examined the products and presence of all major players across the globe.The analyst calculated the market size of global Ibuprofen market using a bottom-up approach, wherein data for various end-user segments was recorded and forecast for the future years. The analyst sourced these values from the industry experts and company representatives and externally validated through analyzing historical data of these services and applications for getting an appropriate, overall market size.Various secondary sources such as company websites, news articles, press releases, company annual reports, investor presentations and financial reports were also studied by the analyst.Key Target Audience:• Ibuprofen manufacturers• Market research and consulting firms• Government bodies such as regulating authorities and policy makers• Organizations, forums, and alliances related to IbuprofenThe study is useful in providing answers to several critical questions that are important for the industry stakeholders such as manufacturers, suppliers and partners, end users, etc., besides allowing them in strategizing investments and capitalizing on market opportunities.Report Scope:In this report, global ibuprofen market has been segmented into following categories, in addition to the industry trends which have also been detailed below:• Global Ibuprofen Market, By Product Type:o Tableto Capsuleo Syrupo Injection• Global Ibuprofen Market, By Route of Administration:o Oralo Intravenous• Global Ibuprofen Market, By Application:o Rheumatoid Arthritis and Osteoarthritiso Ankylosing Spondylitiso Inflammatory Diseaseso Dysmenorrheao Others• Global Ibuprofen Market, By Age Group:o Adulto Pediatric• Global Ibuprofen Market, By Source:o Contract Manufacturing Organizations (CMO)o In-House• Global Ibuprofen Market, By End User:o Hospitalso Clinicso Others• Global Ibuprofen Market, By Distribution Channelo Offlineo Online• Global Ibuprofen Market, By Region:o North America United States Canada Mexicoo Europe Germany France United Kingdom Italy Spaino Asia-Pacific China India Japan Australia South Koreao South America Brazil Argentina Colombiao Middle East & Africa South Africa Saudi Arabia UAECompetitive LandscapeCompany Profiles: Detailed analysis of the major companies present in global ibuprofen market.Available Customizations:With the given market data, we offers customizations according to a company’s specific needs. The following customization options are available for the report:Company Information• Detailed analysis and profiling of additional market players (up to five).Read the full report: ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________

Financial StatementAcquisition

100 Deals associated with Shandong Xinhua Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shandong Xinhua Pharmaceutical Co., Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Cefaclor ( PBPs )	Bacterial Infections More	Approved
Etofesalamide	Chronic eczema More	Approved
Levodopa/Benserazide Hydrochloride ( DDC )	Parkinson Disease More	Approved
Irisquinone	Esophageal Carcinoma More	Approved
Acetamide	Brain Injuries More	Approved

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