[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover, fasting/fed bioequivalence study of dextromethorphan hydrobromide tablets in healthy Chinese subjects

主要研究目的：健康受试者空腹或餐后状态下，单次口服广州白云山光华制药股份有限公司生产的受试制剂氢溴酸右美沙芬片（规格：15mg）或Bayer Hispania, S.L.持证、DELPHARM EVREUX生产的参比制剂氢溴酸右美沙芬片（商品名：Romilar®；规格：15mg），分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。次要研究目的：考察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main study purpose: To examine the pharmacokinetic parameters of the test preparation and the reference preparation in the fasting or postprandial state in healthy subjects by taking a single oral dose of the test preparation Dextromethorphan Hydrobromide Tablets (Specification: 15 mg) produced by Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. or the reference preparation Dextromethorphan Hydrobromide Tablets (trade name: Romilar®; Specification: 15 mg) produced by Bayer Hispania, S.L. and DELPHARM EVREUX, respectively, and evaluate the bioequivalence of the two preparations. Secondary study purpose: To examine the safety of the test preparation and the reference preparation in healthy subjects.

Start Date04 Jul 2023

Sponsor / Collaborator

Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

CTR20221075

/ CompletedNot Applicable

格列齐特片在健康人体内的生物等效性试验

[Translation] Bioequivalence study of gliclazide tablets in healthy volunteers

主要目的：以广州白云山光华制药股份有限公司研发的格列齐特片（规格：80mg）为受试制剂，按生物等效性研究的有关规定，以Servier Laboratories Ltd持证的格列齐特片（规格：80mg，商品名：Diamicron®）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂与参比制剂的生物等效性。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: Gliclazide tablets (specification: 80 mg) developed by Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence studies, Gliclazide tablets (specification: 80 mg, trade name: Diamicron®) certified by Servier Laboratories Ltd were used as the reference preparation. Human bioequivalence studies were conducted in the fasting/postprandial state to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date09 May 2022

Sponsor / Collaborator

Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

CTR20211744

/ CompletedNot Applicable

枸橼酸西地那非片在中国男性受试者中空腹与餐后单次用药、两制剂、两周期、随机、开放、自身交叉的生物等效性试验

[Translation] A two-formulation, two-period, randomized, open-label, self-crossover bioequivalence study of sildenafil citrate tablets in Chinese male subjects after fasting and postprandial single-dose administration

主要研究目的本研究考察空腹和餐后条件下单次口服广州白云山光华制药股份有限公司生产的受试制剂枸橼酸西地那非片（100mg/片）与辉瑞制药有限公司生产的参比制剂枸橼酸西地那非片（商品名：万艾可®， 100mg/片）的相对生物利用度，考察两制剂的生物等效性，为仿制药的质量和疗效一致性评价提供依据。次要研究目的观察受试制剂和参比制剂在中国健康男性受试者中的安全性。

[Translation]

Main study purpose This study investigated the relative bioavailability of the test preparation Sildenafil Citrate Tablets (100 mg/tablet) produced by Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. and the reference preparation Sildenafil Citrate Tablets (trade name: Viagra®, 100 mg/tablet) produced by Pfizer Pharmaceuticals Co., Ltd. after a single oral administration under fasting and postprandial conditions, and investigated the bioequivalence of the two preparations to provide a basis for the quality and efficacy consistency evaluation of generic drugs. Secondary study purpose Observe the safety of the test preparation and the reference preparation in healthy male subjects in China.

Start Date19 Jul 2021

Sponsor / Collaborator

Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

100 Clinical Results associated with Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

0 Patents (Medical) associated with Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

Literatures (Medical) associated with Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

Yaoxue Yanjiu

Network pharmacology based analysis and confirmation of the antipyretic mechanism of Xiaochaihu Granules

Author: Zheng Ruwen ; Ma Rong ; Jiang Yanfengyang ; Zhang Junhua ; Jiang Zhiqiang ; Xu Zhaodong ; Bi Cong ; Liu Hong

Objective To explore the mol. mechanism of antipyretic effect of Xiaochaihu Granules(XCHG).Methods The chem. components of XCHG were separated and identified by fingerprint and UHPLC-MS technol.The targets of components were obtained and classified using PubChem, Swiss and chEMBL databases.The targets of fever were obtained from GeneCard and DisGeNET database.The drug targets and fever targets were intersected, the antipyretic targets database of XCHG was structured and the functional enrichment was analyzed.The model of rats induced by dried yeast was established, and the temperature of rats was monitored within 24 h and the content of cytokines in serum was detected.Results 66 chem. components and 68 potential antipyretic targets of XCHG was screened out.Enzymes, including kinase, protease, oxidoreductase and phosphatase, were the most widely classified category.Compared with aspirin, XCHG could significantly reduce the body temperature of rats with fever at 4∼24 h after modeling, and the effect of medium dose and high dose were similar to that of aspirin.XCHG could significantly reduce the content of TNF-α, IL-6, IFN-γ, IL-1 β and PTGS2, also could decreased the lever of NF-κB and AP-1.Conclusion XCHG can significantly lower the body temperature of rats with fever induced by dried yeast in the rising, peak and falling periods.The antipyretic mechanism of XCHG is related to many links of fever, which may be related to reducing the level of inflammation, inhibiting endogenous pyrogen and PTGS2.

Frontiers in Endocrinology

Effects of Chenpi Jiaosu on serum metabolites and intestinal microflora in a dyslipidemia population: a randomized controlled pilot trial

Article

Author: Yang, Zhimin ; Wang, Chengcheng ; Liu, Xin ; Tan, Fei ; Zheng, Yuying ; Chen, Xinyan ; Su, Weiwei ; Huang, Jiaying

IntroductionDyslipidemia is a critical risk factor for atherosclerosis and cardiovascular/cerebrovascular events, necessitating effective long-term management. However, conventional lipid-lowering drugs such as statins and fibrates are limited by adverse effects, including hepatotoxicity and myopathy, which restrict their prolonged use. Traditional Chinese medicine (TCM) and natural health products offer potential alternatives with multi-target mechanisms and improved safety profiles. Tangerine Peel Enzyme Drink (CPJS), a fermented health product derived from tangerine peel, has demonstrated lipid-modulating properties. This study aimed to evaluate the efficacy and safety of CPJS in improving dyslipidemia and explore its underlying metabolic and microbiological mechanisms.MethodsA randomized, double-blind, parallel-controlled clinical trial was conducted with 72 participants (55 completers). Participants were divided into CPJS and control groups, receiving an 8-week intervention. Primary outcomes included changes in body weight and serum triglycerides (TG), while safety was assessed via liver/kidney function, creatine kinase, blood, and urine tests. Serum metabolomics (93 differential metabolites identified) and intestinal microbiota analysis were performed to elucidate metabolic pathways and microbial shifts. KEGG enrichment analysis mapped metabolites to biological pathways, such as lipid and amino acid metabolism.ResultsThe CPJS group exhibited significant reductions in body weight and TG levels post-intervention (p < 0.05), with no adverse effects observed in safety biomarkers. Metabolomic profiling revealed alterations in fatty acyl, glycerophospholipid, and organic acid metabolites, indicating CPJS modulates lipid metabolism and energy homeostasis. KEGG analysis linked these changes to pathways including triglyceride degradation and amino acid metabolism. Additionally, CPJS increased specific gut microbial taxa associated with lipid regulation, suggesting a microbiome-mediated mechanism.DiscussionCPJS demonstrates efficacy in improving dyslipidemia through dual mechanisms: direct modulation of triglyceride metabolism and indirect regulation via gut microbiota. Its safety profile aligns with findings from natural products like Cyclocarya paliurus and tempeh, which mitigate lipid abnormalities without hepatotoxicity. The multi-target action of CPJS mirrors TCM principles, where compounds like quercetin and flavonoids in CPJS may synergistically inhibit cholesterol synthesis and enhance lipid clearance. However, further research is needed to isolate active components and validate microbial contributions. Compared to synthetic drugs, CPJS offers a safer adjunct therapy, addressing limitations of current pharmacotherapies. Future studies should explore dose-response relationships and long-term outcomes in diverse populations.

Yaoxue Yanjiu

Progress in pharmacological study of Xiaochaihu Granules

Author: Zhang Junhua ; Jiang Zhiqiang ; Bi Cong ; Wang Yonggang ; He Yixi ; Yao Hongliang ; Zheng Ruwen ; Liu Hong ; Wu Hao

Xiaochaihu Granules( XCHG) has the functions of inducing sweat to dispel heat and protecting injured liver and stomach.In this paper, based on the existing pharmacol. researches and clin. practices, the protective effects of XCHG, such as antiviral actions, antipyretic effects, anti-inflammation, immune regulation, liver and stomach protection, and reducing hormone side effects, were systematically reviewed to provide helpful reference for the XCHG's further research and development.

100 Deals associated with Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

100 Translational Medicine associated with Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

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Approved

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Drug(Targets)	Indications	Global Highest Phase

Aceclofenac ( COXs )	Osteoarthritis More	Approved
Dextromethorphan Hydrobromide Hydrate ( NMDA receptor x σ1 receptor )	Dry cough More	Approved
Methscopolamine Bromide ( mAChRs )	Peptic Ulcer More	Approved

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