[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover design bioequivalence study of roxithromycin dispersible tablets in healthy subjects under fasting condition

主要目的：评价健康受试者在空腹状态下口服天津梅花生物医药科技有限公司生产的受试制剂罗红霉素分散片与Opella Healthcare International SAS生产的参比制剂罗红霉素片（罗力得®）后是否具有生物等效性。次要目的：观察受试制剂罗红霉素分散片与参比制剂罗红霉素片（罗力得®）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate whether the test preparation Roxithromycin Dispersible Tablets produced by Tianjin Meihua Biopharmaceutical Technology Co., Ltd. and the reference preparation Roxithromycin Tablets (Rolide®) produced by Opella Healthcare International SAS are bioequivalent after oral administration in healthy subjects in the fasting state. Secondary objective: To observe the safety of the test preparation Roxithromycin Dispersible Tablets and the reference preparation Roxithromycin Tablets (Rolide®) in healthy subjects.

Start Date31 Oct 2023

Sponsor / Collaborator

Tianjin Meihua biomedical technology Co.,Ltd.

CTR20221930 / CompletedNot Applicable

罗红霉素分散片在健康受试者中随机、开放、单次给药、两制剂、两序列、两周期、交叉空腹状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, crossover bioequivalence study of roxithromycin dispersible tablets in healthy subjects under fasting conditions

主要目的：以石药集团欧意药业有限公司生产的罗红霉素分散片为受试制剂，按生物等效性试验的有关规定，与Sanofi Winthrop Industrie生产的罗红霉素片（商品名：罗力得，参比制剂）对比在健康人体内的空腹状态下相对生物利用度，考察两制剂的人体生物等效性。次要目的：观察受试制剂罗红霉素分散片和参比制剂罗红霉素片（商品名：罗力得）在健康受试者中的安全性。

[Translation]

Main purpose: Using Roxithromycin Dispersible Tablets produced by CSPC Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the relative bioavailability of Roxithromycin Tablets (trade name: Rolide, reference preparation) produced by Sanofi Winthrop Industrie in the fasting state in healthy humans was compared to investigate the bioequivalence of the two preparations in humans. Secondary purpose: To observe the safety of the test preparation Roxithromycin Dispersible Tablets and the reference preparation Roxithromycin Tablets (trade name: Rolide) in healthy subjects.

Start Date06 Oct 2022

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

CTR20212070 / CompletedNot Applicable

评估受试制剂罗红霉素片（规格：150 mg）与参比制剂（罗力得®）（规格：150 mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation Roxithromycin Tablets (strength: 150 mg) and the reference preparation (Rolide®) (strength: 150 mg) in healthy adult subjects under fasting state

主要试验目的：研究空腹状态下单次口服受试制剂罗红霉素片（规格：150 mg，花园药业股份有限公司生产）与参比制剂罗红霉素片（罗力得®，规格：150 mg；Sanofi Winthrop Industrie, France生产）在健康受试者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂罗红霉素片（规格：150 mg）和参比制剂罗红霉素片（罗力得®）（规格：150 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation roxithromycin tablets (specification: 150 mg, produced by Huayuan Pharmaceutical Co., Ltd.) and the reference preparation roxithromycin tablets (Luolide®, specification: 150 mg; produced by Sanofi Winthrop Industrie, France) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. The secondary purpose of the study is to study the safety of the test preparation roxithromycin tablets (specification: 150 mg) and the reference preparation roxithromycin tablets (Luolide®) (specification: 150 mg) in healthy subjects.

Start Date09 Sep 2021

Sponsor / Collaborator

Zhejiang Garden Pharmaceutical Co., Ltd.

100 Clinical Results associated with Roxithromycin

100 Translational Medicine associated with Roxithromycin

100 Patents (Medical) associated with Roxithromycin

1,584

Literatures (Medical) associated with Roxithromycin

31 Dec 2024·COPD

Alleviatory Role of Panax Notoginseng Saponins in Modulating Inflammation and Pulmonary Vascular Remodeling in Chronic Obstructive Pulmonary Disease: mechanisms and Implications

Article

Author: Zhang, Xiaomei ; Han, Niping ; Qiao, Bo ; Xu, Ou ; Lv, Bijun ; Fan, Qiuyang ; Hu, Yanan

COPD is an inflammatory lung disease that limits airflow and remodels the pulmonary vascular system. This study delves into the therapeutic potential and mechanistic underpinnings of Panax notoginseng Saponins (PNS) in alleviating inflammation and pulmonary vascular remodeling in a COPD rat model. Symmap and ETCM databases provided Panax notoginseng-related target genes, and the CTD and DisGeNET databases provided COPD-related genes. Intersection genes were subjected to protein-protein interaction analysis and pathway enrichment to identify downstream pathways. A COPD rat model was established, with groups receiving varying doses of PNS and a Roxithromycin control. The pathological changes in lung tissue and vasculature were examined using histological staining, while molecular alterations were explored through ELISA, RT-PCR, and Western blot. Network pharmacology research suggested PNS may affect the TLR4/NF-κB pathway linked to COPD development. The study revealed that, in contrast to the control group, the COPD model exhibited a significant increase in inflammatory markers and pathway components such as TLR4, NF-κB, HIF-1α, VEGF, ICAM-1, SELE mRNA, and serum TNF-α, IL-8, and IL-1β. Treatment with PNS notably decreased these markers and mitigated inflammation around the bronchi and vessels. Taken together, the study underscores the potential of PNS in reducing lung inflammation and vascular remodeling in COPD rats, primarily via modulation of the TLR4/NF-κB/HIF-1α/VEGF pathway. This research offers valuable insights for developing new therapeutic strategies for managing and preventing COPD.

30 Dec 2024·RAPID COMMUNICATIONS IN MASS SPECTROMETRY

Structural elucidation of 14‐membered ring macrolide antibiotics using electrospray ionization tandem mass spectrometry and density functional theory calculations

Article

Author: Vessecchi, Ricardo ; Carnevale Neto, Fausto

Rationale:

Macrolides are critical antibiotics featuring a macrocyclic lactone core with deoxy sugars. Understanding their gas‐phase fragmentation is challenging but essential for improving structural elucidation in mass spectrometry, which has implications for drug discovery and development.

Methods:

We used electrospray ionization collision‐induced dissociation tandem mass spectrometry (ESI‐CID‐MS) combined with quantum chemical calculations to investigate the fragmentation pathways of erythromycin A and roxithromycin. This approach helps elucidate the preferred fragmentation routes influenced by protonation sites.

Results:

Macrolides showed similar fragmentation patterns, including sequential losses of saccharide or amino sugar units and dehydration from the macrocycle core. Multiple competitive pathways were observed, influenced by protonation sites. Computational studies confirmed the most favorable protonation sites and their impact on fragmentation, providing insights into key diagnostic product ions. Subsequent fragments involved rearrangement pathways such as alkene formation and cleavages via remote hydrogen transfers and pericyclic reactions.

Conclusions:

Our integrated approach offers a comprehensive understanding of macrolide fragmentation, enhancing structural elucidation and potential applications in drug development. This study advances mass spectrometry analysis of macrolides, contributing to pharmaceutical research by integrating orthogonal annotation methods and fragmentation studies.

08 Dec 2024·Huan jing ke xue= Huanjing kexue

[Spatial Distribution Characteristics and Ecological Risks of Typical Drugs in the Yongjiang River Basin].

Article

Author: Tang, Jian-Feng ; Guo, Tao ; Wang, Xiang-Fen ; Geng, Chun-Nü ; Du, Miao-Rou ; Wan, Jie-Ting

In recent years, due to large-scale production and widespread use, drugs have posed a potential threat to biological and human health and have received increasing attention. The occurrence and distribution of drugs in urban rivers are influenced by various factors, such as urbanization level, population density, regional geographical and climatic characteristics, and drug consumption habits. In October 2022, the Yongjiang River Basin was divided into four sub-basins： upstream, midstream, tributaries, and downstream. A total of 20 surface water and sediment samples were collected to explore the occurrence, spatial distribution, and ecological risks of drugs in water and sediment. Among the 40 target drugs, 22 drugs were detected in water samples, accounting for 55% of the target drugs, with a maximum concentration of 207.25 ng·L^-1, and 12 drugs were detected in sediment, accounting for 30% of the target drug, with a maximum concentration of 153.63 μg·kg^-1. The dominant species in water samples were metabolic drugs. In sediment, the dominant species in the upstream and midstream were quinolone antibiotics, while the dominant species in the tributaries and downstream were cardiovascular drugs. Nine drugs were detected in both water and sediment, with an apparent distribution coefficient K_d value of 5.0-385 029 L·kg^-1. According to the average lgK_oc value, the order from highest to lowest was： sertraline hydrochloride > ofloxacin > clarithromycin > D,L-venlafaxine > roxithromycin > sulfamethoxazole > fluoxetine > metoprolol > carbamazepine. Principal component analysis was used to analyze the source of drugs in water and four principal components explained 76.24% of the variation, corresponding to a source of medical wastewater, a mixed source of domestic wastewater and aquaculture wastewater, an untreated source of rural domestic wastewater, and an agricultural non-point source. Principal component analysis coupled multiple linear regression analysis well predicted the total concentration of drugs in 20 water samples （R² = 0.868）. Three drugs were present in the water sample that posed ecological risks, with risk quotients in the order of 1,7-dimethylxanthine > dehydrated erythromycin > carbamazepine, whereas only carbamazepine in sediment posed ecological risks. The cumulative risk quotient of multiple drugs in the water at 20 sampling sites was 1.22-16.27, all of which belonged to high risk, while the cumulative risk quotient of multiple drugs in sediment was 0.009~0.064, with no risk at site S11 and low risk at all other sites. The research results can be used to analyze the distribution mechanism of drugs between water and sediment, providing a technical basis for the prevention and control of drug pollution and environmental risks in urban rivers.

News (Medical) associated with Roxithromycin

15 Dec 2022

·www.prnewswire.com

China Pharma Holdings, Inc. Announced that several products are included in the Catalogue of Medicines for People Infected with COVID-19

HAIKOU, China, Dec. 15, 2022 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma", the "Company" or "We"), an NYSE American-listed corporation with a fully-integrated specialty pharmaceuticals subsidiary based in China, today announced that its drugs were listed in The Catalogue of Medicines for People Infected with COVID-19 (First Edition) (hereinafter referred to as the Catalogue) published by People's Daily on December 12, 2022. Recently, China has completely ended its strict quarantine and zero case policies in response to COVID-19 pandemic in the past three years. Out of concern about the spread of the epidemic, people began to hoard many related drugs. The Chinese government has issued the Catalogue to guide people to take drugs accordingly. A series of drugs of our Company are listed in the catalog, and the demand is huge. Our modern Traditional Chinese Medicine (TCM) anti-virus product: Andrographolide has been listed in the Catalogue Our cold medicine: Naproxen Sodium and Pseudoephedrine Hydrochloride Sustained Release Tablets (brand name, Pusen OK), in which the compound ingredient pseudoephedrine is in line with the cold symptom relief medicine recommended in the Catalog It was announced in many places in China in recent days that pharmacies will no longer register or upload customer information on "four types of drugs", which includes anti-fever, cough, antiviral and antibiotic drugs. This will benefit the sales of our main products, roxithromycin and cefaclor The market demand for our masks has also increased significantly Ms. Li Zhilin, CEO of China Pharma said: " With the liberalization of epidemic risk control measures across China, the number of infected people may rise rapidly. The public's need in keeping certain epidemic prevention materials and related drugs has been dramatically increasing. As a professional pharmaceutical manufacturer for nearly 30 years, we will continue to spare no effort to provide high-quality products to protect people's health." About China Pharma Holdings, Inc. China Pharma Holdings, Inc. (NYSE American: CPHI) is a specialty pharmaceutical company that develops, manufactures, and markets a diversified portfolio of products, focusing on conditions with high incidence and high mortality rates in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company's cost-effective business model is driven by market demand and supported by new GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding nationwide distribution network across all major cities and provinces in China. The Company's wholly-owned subsidiary, Hainan Helpson Medical & Biotechnology Co., Ltd., is located in Haikou City, Hainan Province. For more information about China Pharma Holdings, Inc., please visit . The Company routinely posts important information on its website. Safe Harbor Statement Certain statements in this press release constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any statements set forth above that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties may include, but are not limited to: the achievability of financial guidance; success of new product development; unanticipated changes in product demand; increased competition; downturns in the Chinese economy; uncompetitive levels of research and development; and other information detailed from time to time in the Company's filings and future filings with the United States Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this press release and the Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations, except as required by applicable law or regulation. SOURCE China Pharma Holdings, Inc.

100 Deals associated with Roxithromycin

External Link

KEGG	Wiki	ATC	Drug Bank
D01710	Roxithromycin	J01FA06	DB00778

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Bronchitis	AU	Alphapharm Pty Ltd.	30 Mar 2004
Acute pharyngitis	AU	Alphapharm Pty Ltd.	30 Mar 2004
Acute tonsillitis	AU	Alphapharm Pty Ltd.	30 Mar 2004
Bronchitis, Chronic	AU	Alphapharm Pty Ltd.	30 Mar 2004
Community Acquired Pneumonia	AU	Alphapharm Pty Ltd.	30 Mar 2004
Impetigo	AU	Alphapharm Pty Ltd.	30 Mar 2004
Lower Respiratory Tract Infections	AU	Alphapharm Pty Ltd.	30 Mar 2004
non-gonococcal urethritis (NGU)	AU	Alphapharm Pty Ltd.	30 Mar 2004
Respiratory Tract Infections	AU	Alphapharm Pty Ltd.	30 Mar 2004
Tonsillitis	AU	Alphapharm Pty Ltd.	30 Mar 2004
Acne Vulgaris	JP	Sanofi KK	18 Jan 1991
Laryngitis	JP	Sanofi KK	18 Jan 1991
Lymphadenitis	JP	Sanofi KK	18 Jan 1991
Pharyngitis	JP	Sanofi KK	18 Jan 1991
Pneumonia	JP	Sanofi KK	18 Jan 1991
Sinusitis	JP	Sanofi KK	18 Jan 1991
Skin and skin structure infections	JP	Sanofi KK	18 Jan 1991
Infectious Diseases	CN	Shenyang Hongqi Pharmaceutical Co., Ltd.	01 Jan 1989

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00439062 (Pubmed \| Postgrad Med)	Phase 4	Rheumatoid Arthritis	100	Roxithromycin 300 mg	myxvzdwlon(pbsrqajbha) = lbamcmthnx kwmvfpzgmf (spungmhfoa ) View more	Positive	01 Sep 2011
				Placebo	myxvzdwlon(pbsrqajbha) = dwlnamayuq kwmvfpzgmf (spungmhfoa ) View more

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