[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 of the formula rules of Xiaochaihu Granules

Author: Zhang Junhua ; Jiang Zhiqiang ; Wang Yonggang ; Bi Cong ; Huang Haitao ; He Yixi ; Ma Rong ; Huang Wei ; Zheng Ruwen ; Wu Hao ; Liu Hong

Objective This study was designed to reveal the formula rules of Xiaochaihu Granules(XCHG) based on the network pharmacol. technol.Methods The active components and targets of XCHG were selected through the databases and literatures, and the interactive anal. was carried out among the herbs.The herb-component-target network of XCHG was built, and the KEGG pathways of herbs were enriched.The antipyretic mechanisms and the formula rules of XCHG were explained based on the TNF pathways.Results Nine components, such as quercetin and β-sitosterol, were shared by two or more herbs.The targets and pathways of the monarch herb CH were enriched in antiviral, antipyretic, immune, inflammatory effects, etc., which played a leading role in the XCHG prescription.The minister herb HQ could enhance the effect of CH, and meantime increase XCHG′s antibacterial effects.The adjuvant herb DS and DZ could replenish Qi to invigorate the spleen and nourishing blood to promote body fluid, through the endocrine, relaxin, and cardiovascular pathways and targets;BX and SJ could harmonize the stomach and stop vomit, through the nerve activity, nerve conduction, and hormone secretion pathways and targets.Guide herb GC could influence the metabolism and distribution of drugs to harmonize seven herbs.Conclusion In terms of antipyretic mechanisms, XCHG′s twenty-seven targets were enriched in TNF signaling pathway, in which five targets were acted by all the seven herbs(NF-κB, AP-1, PTGS2, MMP9 and CASP3), performing key roles in the antipyretic effect.This study demonstrated that the effects of XCHG formula are probably through the superposition of single-component concentration, superposition of single-target action, and multi-target cooperation.

Zhongshan Daxue Xuebao, Ziran Kexueban, Zhong Ying Wen

The biological target network and underlying mechanisms analysis of Xiaochaihu Granule(XCHG)

Author: Zhang Junhua ; Liao Yan ; Yao Hongliang ; Bi Cong ; He Yixi ; Zheng Ruwen ; Du Haiyong ; Liu Hong ; Jiang Zhiqiang ; Chen Xiuli ; Peng Wei

Xiaochaihu Granule(XCHG)is a famous traditional Chinese medicine(TCM)firstly studied and developed by the Guangzhou Baiyunshan Guanghua Pharmaceotical Co., LTD.The study aimed to investigate the biol. target network and potential mechanisms of XCHG through network pharmacol. techniques.The compounds and targets of XCHG were screened using TCMSP, PubMed, and UniProt databases.The protein-protein interaction network was analyzed by String and Cytoscape.The GO functions and KEGG pathways were enriched.The active component-target-pathway network of XCHG was established.The results showed that 82 active compounds and 242 potential targets were obtained in XCHG.Wherein, Quercetin, Kaempferol, Luteolin, Wogonin, Naringenin, 7-Methoxy-2-Me isoflavone, Baicalein, Formononetin, Stigmasterol, and β-sitosterol were the main active compounds;VEGFA, JUN, MAPK3, AKT1, MMP9, IL6, ALB, PTGS2, CXCL8, and CASP3 were the key targets;Twenty key pathways were enriched, and 50% of them were closely related to antiviral effects, such as Human cytomegalovirus infection, Influenza A, Epstein-Barr virus infection, etc.Other major pathways include immune-and inflammation-related pathways such as PI3 K-Akt pathway, MAPK pathway, TNF pathway, etc., and apoptosis-related pathways such as Apoptosis pathway, etc.This study showed the advantages of XCHG in suppressing virus replication and viral infection, revealed the key targets and pathways in regulating immune and inflammatory response, and cell apoptosis.The results provided helpful references for XCHG's mechanism explanation and clin. administration.

Zhongguo Zhongyao Zazhi

Two new sucrose cinnamates from Polygonum lapathifolium var. salicifolium

Author: Chen Zhi-hua ; Jiang Ren-wang ; Wang Guo-en

Two new sucrose cinnamates(1 and 2) along with nine known compounds(3-11) were isolated from ethanol extract of Polygonum lapathifolium var. salicifolium by silica gel column chromatog., ODS column chromatog. and semi-preparative HPLC.Their structures were elucidated by extensive spectroscopic methods including 1 D-and 2 D-NMR experiments, as well as HR-ESI-MS anal.Eleven compounds(7 sucrose cinnamates, 3 phenylpropanoids and 1 lactone) were obtained and their structures were identified as(1, 3-O-di-p-coumaroyl)-β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside(1), (1, 3-O-di-p-coumaroyl)-β-D-fructofuranosyl-(2→1)-(6-O-acetyl)-α-D-glucopyranoside(2), (3-O-feruloyl)-β-D-fructofuranosyl-(2→1)-(6-O-p-coumaroyl)-α-D-glucopyranoside(3), hydropiperoside(4), vanicoside C(5), (1, 3-O-di-p-coumaroyl)-β-D-fructofuranosyl-(2→1)-(6-O-feruloyl)-α-D-glucopyranoside(6), vanicoside B(7), trans-p-hydroxycinnamic acid Me ester(8), trans-p-hydroxycinnamic acid Et ester(9), Me ferulate(10) and dimethoxydimethylphthalide(11), resp.Compounds 1 and 2 were two new sucrose cinnamates, and compounds 1-11 were isolated from this plant for the first time.The antioxidant activities of the isolated compounds 1-9 were investigated by an oxygen radical absorbance capacity(ORAC) assay, and all nine compounds were found to show strong antioxidant activities.Among them, compound 6(10 μmol·L∼(-1)) was the supreme one in antioxidant activities, with its ORAC value equivalent to(1.60±0.05) times of 50 μmol·L∼(-1) Trolox.

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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Drug(Targets)	Indications	Global Highest Phase

Aceclofenac ( COX )	Rheumatoid Arthritis More	Approved
Dextromethorphan Hydrobromide Hydrate ( NMDA receptor x σ1 receptor )	Dry cough More	Approved
Methscopolamine Bromide ( mAChRs )	Nausea More	Approved

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