[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover fasting and fed bioequivalence study of faropenem sodium tablets in healthy subjects

本试验旨在研究健康受试者单次空腹和餐后口服海南海灵化学制药有限公司研制、生产的法罗培南钠片（200 mg）的药代动力学特征；以Maruho Co., Ltd持证、生产的法罗培南钠片（Farom®，200 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of faropenem sodium tablets (200 mg) developed and produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration in healthy subjects; Faropenem sodium tablets (Farom®, 200 mg) licensed and produced by Maruho Co., Ltd were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date02 Sep 2024

Sponsor / Collaborator

Hainan Hailing Chemipharma Corp. Ltd.

CTR20240467 / CompletedNot Applicable

广东九明制药有限公司研制的小儿法罗培南钠颗粒与Maruho Co.,Ltd.持证的小儿法罗培南钠颗粒（商品名：菲若姆®，规格：0.05 g）在中国健康成年受试者中进行的单中心、随机、开放、两制剂、空腹及餐后、单次给药、两周期、双交叉设计的生物等效性研究。

[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study was conducted in healthy adult subjects in China. The pediatric faropenem sodium granules developed by Guangdong Jiuming Pharmaceutical Co., Ltd. and the pediatric faropenem sodium granules (trade name: Feroum®, specification: 0.05 g) were compared with the pediatric faropenem sodium granules (trade name: Feroum®, specification: 0.05 g) approved by Maruho Co., Ltd.

以广东九明制药有限公司提供的小儿法罗培南钠颗粒（规格：0.05 g）为受试制剂，以持证商为Maruho Co.,Ltd.的小儿法罗培南钠颗粒（商品名：菲若姆®，规格：0.05 g）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

The pediatric faropenem sodium granules (specification: 0.05 g) provided by Guangdong Jiuming Pharmaceutical Co., Ltd. were used as the test preparation, and the pediatric faropenem sodium granules (trade name: Feroum®, specification: 0.05 g) from the licensed manufacturer Maruho Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated in the fasting and postprandial states, and the bioequivalence of the two preparations was evaluated. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date30 Jul 2024

Sponsor / Collaborator

Guangdong Jiu Ming Pharmaceutical Co., Ltd.

CTR20241803 / CompletedNot Applicable

小儿法罗培南钠颗粒在中国健康受试者中随机、开放、单剂量、两序列、两周期、双交叉、餐后给药条件下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover, postprandial bioequivalence study of faropenem sodium granules in Chinese healthy subjects

主要研究目的本试验以北京民康百草医药科技有限公司持证的小儿法罗培南钠颗粒，规格：0.05g（以C12H15NO5S计）为受试制剂，以Maruho Co.,Ltd.（玛路弘株式会社）持证的小儿法罗培南钠颗粒（商品名：菲若姆），规格：0.05g（以C12H15NO5S计）为参比制剂，评估受试制剂和参比制剂在餐后条件下的生物等效性。次要研究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 study purpose This study uses the certified pediatric faropenem sodium granules of Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd., specification: 0.05g (calculated as C12H15NO5S) as the test preparation, and the certified pediatric faropenem sodium granules (trade name: Feromu) of Maruho Co., Ltd., specification: 0.05g (calculated as C12H15NO5S) as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under postprandial conditions. Secondary study purpose Observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date23 Jun 2024

Sponsor / Collaborator

Beijing Minkang Baicao Medicine Technology Co.,Ltd.

100 Clinical Results associated with Faropenem Sodium Hydrate

100 Translational Medicine associated with Faropenem Sodium Hydrate

100 Patents (Medical) associated with Faropenem Sodium Hydrate

237

Literatures (Medical) associated with Faropenem Sodium Hydrate

18 Oct 2023·Antimicrobial agents and chemotherapy

Impact of acquired broad-spectrum β-lactamases on susceptibility to oral penems/carbapenems (tebipenem, sulopenem, and faropenem) alone or in combination with avibactam and taniborbactam β-lactamase inhibitors in Escherichia coli.

Article

Author: Le Terrier, Christophe ; Nordmann, Patrice ; Bouvier, Maxime ; Poirel, Laurent

The impact of β-lactamases on susceptibility to oral penems/carbapenems (tebipenem, sulopenem, and faropenem) and other carbapenem molecules was evaluated in Escherichia coli, alone and in combination with avibactam or taniborbactam β-lactamase inhibitors. Tebipenem and sulopenem exhibited a similar spectrum of activity compared to the intravenous carbapenems and displayed lower MIC values than ceftibuten-avibactam against E. coli producing extended-spectrum β-lactamases or AmpC enzymes. Combined with taniborbactam, tebipenem and sulopenem exhibited low MIC values against almost all tested recombinant E. coli, including metallo-β-lactamase producers.

01 Oct 2023·Journal of Pharmaceutical and Biomedical Analysis

SERS study of classical and newly β-lactams-metal complexation based on in situ laser-induced coral reefs-like silver photomicroclusters: In vitro study of antibacterial activity

Article

Author: Mahmoud, Amer F ; El-Zahry, Marwa R ; Nasr, Jenny Jeehan M ; Al-Shaalan, Nora H

The influence of metal complexation of two polar β-lactam antibiotics was investigated using surface enhanced Raman spectroscopy (SERS) technique. SERS method was applied to track the structural changes and the degradation behaviour of the studied compounds upon Zinc (II) ions-complexation. In situ laser-induced coral reefs-like photomicroclusters have been utilized as a SERS platform. The produced coral reefs-like photomicroclusters were characterized using scanning electron microscopy (SEM) and transmission electron microscope (TEM). The antibacterial efficiency of the antibiotics was investigated and compared before and after metal complexation using two techniques; agar well diffusion and growth curve. To provide a detailed elucidation of the complexation reaction, mass fragmentation of metal- antibiotics complexes was investigated using liquid chromatography/mass spectrometric (LC/MS) technique. It was found that metal complexation of classical β-lactam antibiotic (Ticarcillin) promoted the rate of its degradation, leading to a decrease of the antibacterial efficiency. On the other side, the antibacterial activity of the newly developed β-lactam (Faropenem) has been greatly enhanced via metal-complexation reaction.

01 Sep 2023·Clinical Microbiology and Infection

Proteus mirabilis – analysis of a concealed source of carbapenemases and development of a diagnostic algorithm for detection

Article

Author: Dorth, Vivien ; Göttig, Stephan ; Fuchs, Frieder ; Gatermann, Sören G ; Hamprecht, Axel ; Noster, Janina ; Stelzer, Yvonne ; Sattler, Janko

OBJECTIVESTo analyse carbapenemases in Proteus mirabilis and assess the performance of carbapenemase detection assays.METHODSEighty-one clinical P. mirabilis isolates with high-level resistance at least to ampicillin (>32 mg/L) or previous detection of carbapenemases were selected and investigated by three susceptibility testing methods (microdilution, automated susceptibility testing, and disk diffusion), six phenotypic carbapenemase assays (CARBA NP, modified carbapenemase inactivation method [CIM], modified zinc-supplemented CIM, simplified CIM, faropenem, and carbapenem-containing agar), two immunochromatographic assays, and whole-genome sequencing.RESULTSCarbapenemases were detected in 43 of 81 isolates (OXA-48-like [n = 13]; OXA-23 [n = 12]; OXA-58 [n = 12]; New Delhi metallo-β-lactamase (NDM) [n = 2]; Verona integron-encoded metallo-β-lactamase (VIM) [n = 2]; Imipenemase (IMP) [n = 1]; Klebsiella pneumoniae carbapenemase (KPC) [n = 1]). Carbapenemase-producing Proteus were frequently susceptible to ertapenem (26/43; 60%), meropenem (28/43; 65%), ceftazidime (33/43; 77%), and some even to piperacillin-tazobactam (9/43; 21%). Sensitivity/specificity of phenotypic tests were 30% (CI: 17-46%)/89% (CI: 75-97%) for CARBA NP, 74% (CI: 60-85%)/82% (CI: 67-91%) for faropenem, 91% (CI: 78-97%)/82% (CI: 66-92%) for simplified CIM, and 93% (CI: 81-99%)/100% (CI: 91-100%) for modified zinc-supplemented CIM. An algorithm for improved detection was developed, which demonstrated sensitivity/specificity of 100% (CI: 92-100%)/100% (CI: 91-100%) on the 81 isolates, and 100% (CI: 29-100%)/100% (CI: 96-100%) in a prospective analysis of additional 91 isolates. Interestingly, several OXA-23-producing isolates belonged to the same clonal lineage reported previously from France.DISCUSSIONCurrent susceptibility testing methods and phenotypic tests frequently fail to detect carbapenemases in P. mirabilis, which could result in inadequate antibiotic treatment. In addition, the non-inclusion of bla_{OXA-23/OXA-58} in many molecular carbapenemase assays further impedes their detection. Therefore, the prevalence of carbapenemases in P. mirabilis is likely underestimated. With the herein proposed algorithm, carbapenemase-producing Proteus can be easily identified.

100 Deals associated with Faropenem Sodium Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D01839	Faropenem Sodium Hydrate	J01DI03	DB12190

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	CN	Shandong New Time Pharmaceutical Co. Ltd.	30 May 2006
Skin Diseases, Infectious	CN	Shandong New Time Pharmaceutical Co. Ltd.	30 May 2006
Bacterial Infections	JP	Maruho Co., Ltd.	22 Sep 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Infections	Phase 1	CN	Jiangsu Yangtze River Pharmaceutical Group Co., Ltd.	16 Jun 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02393586 (Pubmed \| J Antimicrob Chemother)	Phase 1	Tuberculosis	43	Faropenem	aonrenvnev(tromuhvxuq) = zlkxgrywvi wuxybueewb (wvkfsrcvds )	-	01 Jul 2017
				Rifampicin	aonrenvnev(tromuhvxuq) = umrdinotxy wuxybueewb (wvkfsrcvds )

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