Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

Start Date01 Aug 2024

Sponsor / Collaborator

The General Hospital Corp.

[+1]

CTR20241005 / CompletedNot Applicable

头孢克洛干混悬剂在健康试验参与者中的随机、开放、单次给药、两制剂、两周期人体生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, two-period human bioequivalence study of cefaclor dry suspension in healthy trial participants

主要研究目的：以江苏正大清江制药有限公司研制的头孢克洛干混悬剂（规格：0.125g）为受试制剂，按生物等效性研究的有关规定，与苏州西克罗制药有限公司生产的头孢克洛干混悬剂（商品名：希刻劳®，参比制剂，规格：0.125g）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：比较头孢克洛干混悬剂受试制剂（规格：0.125g）和参比制剂（规格：0.125g）在健康试验参与者中的安全性。

[Translation]

Main research purpose: The cefaclor dry suspension (specification: 0.125g) developed by Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant provisions of bioequivalence studies, the relative bioavailability of the two preparations in healthy humans was compared with that of the cefaclor dry suspension (trade name: Xikeluo®, reference preparation, specification: 0.125g) produced by Suzhou Xikro Pharmaceutical Co., Ltd. to investigate the human bioequivalence of the two preparations. Secondary research purpose: Compare the safety of the cefaclor dry suspension test preparation (specification: 0.125g) and the reference preparation (specification: 0.125g) in healthy trial participants.

Start Date18 Apr 2024

Sponsor / Collaborator

Jiangsu Chiatai Qingjiang Pharmaceutical Co., Ltd.

CTR20233818 / CompletedNot Applicable

头孢克洛缓释片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后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 cefaclor sustained-release tablets in healthy subjects under fasting/fed conditions

健康受试者空腹/餐后状态下，口服单剂量头孢克洛缓释片（受试制剂T，广州白云山医药集团股份有限公司白云山制药总厂生产，规格：0.375g/片）与头孢克洛缓释片（Ⅱ）（参比制剂R，苏州西克罗制药有限公司生产，商品名：希刻劳®，规格：0.375g/片）后，考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。

[Translation]

Healthy subjects were given a single oral dose of cefaclor sustained-release tablets (test preparation T, produced by Baiyunshan Pharmaceutical Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., specification: 0.375 g/tablet) and cefaclor sustained-release tablets (II) (reference preparation R, produced by Suzhou Xikro Pharmaceutical Co., Ltd., trade name: Xikro®, specification: 0.375 g/tablet) in the fasting/postprandial state. The absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions were investigated to evaluate whether the test preparation and the reference preparation were bioequivalent.

Start Date03 Jan 2024

Sponsor / Collaborator

Guangzhou Baiyunshan General Pharmaceutical Factory

100 Clinical Results associated with Cefaclor

100 Translational Medicine associated with Cefaclor

100 Patents (Medical) associated with Cefaclor

1,899

Literatures (Medical) associated with Cefaclor

01 Dec 2024·MOLECULAR BIOLOGY REPORTS

Multiplex PCR-based genotyping of Salmonella Enteritidis and Salmonella Typhimurium from food sources and assessment of their antimicrobial resistance profiles in Egypt

Article

Author: Abdel-Mawgood, Ahmed ; Mansour, Hussein ; Barac, Deng ; Awad, Sameh ; Ghazy, Mohamed

BACKGROUND:

Salmonellosis is a widespread zoonotic disease that poses a significant threat to livestock and public health. This study aimed to serotype 20 Salmonella isolates obtained from sixty retail chicken meats, assess Salmonella contamination from eggs, and evaluate antibiotic resistance profiles.

METHODS AND RESULTS:

Twenty eggs were randomly collected in the new Borg El Arab market. Bacterial isolation was carried out utilizing both traditional culture, biochemical, and PCR methods. Among the twenty eggs analyzed, three (15%) tested positive for Salmonella, while the remaining seventeen (85%) were confirmed as negative. Genotyping through multiplex PCR revealed the presence of two S. Enteritidis and other serovar, with the use of three specific gene sets: a random sequence for Salmonella spp., sdfI gene for S. Enteritidis, and flagellin (fliC gene) for S. Typhimurium. Out of the 20 isolates obtained from chicken meat, five (25%) were identified as S. Typhimurium, and three (15%) were classified as S. Enteritidis. All isolates sourced from chicken meat exhibited resistance to Rifampicin and Amoxicillin, with 90% displaying sensitivity to cefotaxime, gemifloxacin, and Erythromycin. Importantly, S. Blegdam, identified via serological methods, displayed resistance to all tested antibiotics. For the three isolates obtained from eggs, 66.6% showed sensitivity to cefotaxime, erythromycin, cefuraxime, and cefaclor, while displaying complete resistance (100%) to Amoxicillin, rifampicin, clarithromycin, and cefadroxil. Notably, one serovar exhibited absolute resistance to all tested drugs.

CONCLUSION:

Stakeholders must implement strict control measures and rationalize antibiotic use in veterinary and human medicine due to the rise of antibiotic-resistant strains.

01 Sep 2024·Drug Research

Cerebroprotective Potential of Andrographolide Nanoparticles: In silico and In vivo Investigations

Article

Author: Gajula, Somasekhar ; Dintakurthi, Prasanth Sree Naga Bala Krishna ; Rudrala, Lakshmi Charitha ; Sirisha Mulukuri, N.V. L. ; Singh, Gagandeep ; Ayyappa Gouru, Sampath ; Pasala, Praveen Kumar ; Rudrapal, Mithun ; Challa, Ranadheer Reddy ; Subramanyam, Sibbala

Abstract:

Ischemic stroke remains the leading cause of death and disability, while the main mechanisms of dominant neurological damage in stroke contain oxidative stress and inflammation. Docking studies revealed a binding energy of − 6.1 kcal/mol for AG, while the co-crystallized ligand (CCl) exhibited a binding energy of − 7.3 kcal/mol with NOS. AG demonstrated favourable hydrogen bond interactions with amino acids ASN A:354 and ARG A:388 and hydrophobic interactions with GLU A:377. Molecular dynamics simulations throughout 100 ns indicated a binding affinity of − 27.65±2.88 kcal/mol for AG, compared to − 18.01±4.02 kcal/mol for CCl. These findings suggest that AG possesses a superior binding affinity for NOS compared to CCl, thus complementing the stability of NOS at the docked site.AG has limited applications owing to its low bioavailability, poor water solubility, and high chemical and metabolic instability.The fabrication method was employed in the preparation of AGNP, SEM analysis confirmed spherical shape with size in 19.4±5 nm and investigated the neuroprotective effect in cerebral stroke rats induced by 30 min of carotid artery occlusion followed by 4 hr reperfusion, evaluated by infarction size, ROS/RNS via GSH, MPO, NO estimationand AchE activity, and monitoring EEG function. Cortex and hippocampal histology were compared between groups. AGNP treatment significantly decreased Infarction size and increased GSH levels (p<0.01**), decreased MPO (p<0.01**), NO (p<0.01**), AchE (p<0.01**), restored to normal EEG amplitude, minimizing unsynchronized polyspikes and histological data revealed that increased pyramidal cell layer thickness and decreased apoptotic neurons in hippocampus, cortex appeared normal neurons with central large vesicular nuclei, containing one or more nucleoli in compared to AG treatment. Based on brain biochemical, histopathology reports AGNP exhibited significant cerebroprotective activity compared to AG on ischemic rats.

31 Jul 2024·Japanese journal of infectious diseases

β-Lactam Susceptibility of <i>Streptococcus dysgalactiae</i> subsp. <i>equisimilis</i>

Article

Author: Jin, Wanchun ; Koyama, Shinobu ; Arakawa, Yoshichika ; Kimura, Kouji ; Tamai, Kiyoko ; Wachino, Jun-Ichi ; Nakashima, Natsumi

All clinical isolates of Streptococcus dysgalactiae subsp. equisimilis (SDSE) are considered susceptible to β-lactams, the first-line drugs used to treat SDSE infections. However, given that penicillin-non-susceptible SDSE strains have been isolated in Denmark, in this study, we aimed to identify β-lactam-non-susceptible clinical isolates of SDSE in Japan. In 2018, we collected 150 clinical isolates of S. dysgalactiae, and species identification was performed using a Rapid ID Strep API kit. The minimum inhibitory concentrations (MIC) of six β-lactams (penicillin G, oxacillin, ceftizoxime, ceftibuten, cefoxitin, and cefaclor) were determined for the 85 clinical isolates identified as SDSE using the agar dilution method standardized by the Clinical & Laboratory Standards Institute. The MIC ranges of penicillin G, oxacillin, ceftizoxime, ceftibuten, cefoxitin, and cefaclor were 0.007-0.06, 0.03-0.12, 0.015-0.06, 0.25-2, 0.12-2, and 0.06-0.5 μg/mL, respectively. None of the clinical isolates of SDSE were non-susceptible to penicillin G, indicating that all 85 clinical isolates of SDSE were susceptible to β-lactams. Our findings indicate that almost all clinical isolates of SDSE, from several prefectures of Japan, are still susceptible to β-lactams. Nevertheless, there remains a need for continuous and careful monitoring of drug susceptibility among clinical SDSE isolates in Japan.

News (Medical) associated with Cefaclor

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.

06 Sep 2017

·www.bioportfolio.com

Yungjin Pharm Co Ltd 003520 Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 22082017] Prices from USD $250

Summary Yungjin Pharm Co Ltd Yungjin, a subsidiary of KTG Corp is a pharmaceutical company that develops, manufactures and distributes active pharmaceutical ingredients, formulations and tonic drinks. The company's API products include cephalosporins and other general products. It also provides cefaclor cap and dry syr, cefadroxil monohydrate, cefalexin monohydrate, cefamandole inj, cefcapene pivoxil tab and fine gran, cefmetazole inj, cefminox inj, cefotaxime inj, and cefatrizine propylene glycolate, among others. Yungjin offers formulation products for various therapeutic areas such as antibiotics, CNS, cardiovascular, endocrine system, respiratory, antiinflammatory and analgesics, antihistamine, antifungal, total nutrition, urinary system, vitamin and supplement, and cosmetics. The company also provides tonic drinks with pidotimod liquid. It operates through research and development institute, and factory located in Korea. Yungjin is headquartered in Seoul, South Korea. Yungjin Pharm Co Ltd 003520 Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

Acquisition

100 Deals associated with Cefaclor

External Link

KEGG	Wiki	ATC	Drug Bank
D02352	Cefaclor	J01DC04	DB00833

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchitis, Chronic	AT	Viatris Pty Ltd.	14 Mar 1997
Acute Bronchitis	JP	Kyowa Pharmaceutical Industry Co., Ltd.	28 Jun 1988
Lymphadenitis	JP	Kyowa Pharmaceutical Industry Co., Ltd.	28 Jun 1988
Pharyngolaryngitis	JP	Kyowa Pharmaceutical Industry Co., Ltd.	28 Jun 1988
Pyoderma	JP	Kyowa Pharmaceutical Industry Co., Ltd.	28 Jun 1988
Secondary infection	JP	Kyowa Pharmaceutical Industry Co., Ltd.	28 Jun 1988
Gram-Negative Bacterial Infections	US	Eli Lilly & Co.	04 Apr 1979
Gram-Positive Bacterial Infections	US	Eli Lilly & Co.	04 Apr 1979
Lower Respiratory Tract Infections	US	Eli Lilly & Co.	04 Apr 1979
Otitis Media	US	Eli Lilly & Co.	04 Apr 1979
Skin and skin structure infections	US	Eli Lilly & Co.	04 Apr 1979
Tonsillitis	US	Eli Lilly & Co.	04 Apr 1979
Urinary Tract Infections	US	Eli Lilly & Co.	04 Apr 1979
Bacterial Infections	GB	Flynn Pharma Ltd.	21 Aug 1978

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