Last update 05 Jul 2024

Norfloxacin

Last update 05 Jul 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

1,4-Dihydro-1-ethyl-6-fluoro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, NFLX

+ [27]

Target

Bacterial DNA gyrase

Mechanism

Bacterial DNA gyrase inhibitors

Therapeutic Areas

Infectious DiseasesEye DiseasesUrogenital Diseases+ [1]

Active Indication

Corneal UlcerBlepharitisConjunctivitis+ [9]

Inactive Indication

Cystitis

Originator Organization

KYORIN Pharmaceutical Co., Ltd.

Active Organization

KYORIN Pharmaceutical Co., Ltd.Central Pharmaceutical JSC No. 3

Nichi-Iko Pharmaceutical Co., Ltd.

Inactive Organization

Merck Research Laboratories Massachusetts LLC

Eurofarma Laboratórios SA

Drug Highest PhaseApproved

First Approval Date

JP (15 Feb 1984),

Infectious Diseases

Regulation-

Structure

Molecular FormulaC16H18FN3O3

InChIKeyOGJPXUAPXNRGGI-UHFFFAOYSA-N

CAS Registry70458-96-7

Clinical Trials associated with Norfloxacin

CTR20241157 / CompletedNot Applicable

诺氟沙星胶囊（0.1g）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of norfloxacin capsules (0.1 g) in Chinese healthy volunteers under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择杏林制药株式会社为持证商的诺氟沙星片（商品名：BACCIDAL®，规格：100mg/片）为参比制剂，对哈药集团制药六厂生产、哈药集团制药总厂提供的受试制剂诺氟沙星胶囊（规格：0.1g/粒）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂诺氟沙星胶囊（规格：0.1g/粒）和参比制剂诺氟沙星片（商品名：BACCIDAL®，规格：100mg/片）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) of which Xinglin Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation norfloxacin capsules (specification: 0.1g/tablet) produced by Harbin Pharmaceutical Group Pharmaceutical Factory No. 6 and provided by Harbin Pharmaceutical Group Pharmaceutical Factory were tested for human bioequivalence under fasting administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and the bioequivalence of the two preparations under fasting administration conditions was evaluated. Secondary research purpose: To observe the safety of oral administration of the test preparation norfloxacin capsules (specification: 0.1g/tablet) and the reference preparation norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) by healthy volunteers.

Start Date15 Apr 2024

Sponsor / Collaborator

Harbin Pharmaceutical Group Co. Ltd. General Pharm Factory

CTR20240282 / CompletedNot Applicable

诺氟沙星胶囊在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹生物等效性试验研究方案

[Translation] Study plan for a single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting bioequivalence trial of norfloxacin capsules in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下口服受试制剂诺氟沙星胶囊（规格：0.1g，持证商：广东恒健制药有限公司）与参比制剂诺氟沙星片（规格：0.1g，持证商：杏林制药株式会社，商品名：BACCIDAL®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂诺氟沙星胶囊和参比制剂诺氟沙星片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation norfloxacin capsule (specification: 0.1g, license holder: Guangdong Hengjian Pharmaceutical Co., Ltd.) and the reference preparation norfloxacin tablet (specification: 0.1g, license holder: Xinglin Pharmaceutical Co., Ltd., trade name: BACCIDAL®) in healthy subjects after oral administration in the fasting state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation norfloxacin capsule and the reference preparation norfloxacin tablet in healthy subjects.

Start Date03 Mar 2024

Sponsor / Collaborator

Jiangmen Hengjian Pharmaceutical Co. Ltd.

CTR20230089 / CompletedNot Applicable

诺氟沙星胶囊在健康受试者中空腹状态下的单中心、随机、开放、两制剂、单剂量、双周期、两序列、双交叉生物等效性试验研究方案

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, two-sequence, double-crossover bioequivalence study protocol for norfloxacin capsules in healthy subjects under fasting condition

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下口服受试制剂诺氟沙星胶囊（生产厂家：武汉同济现代医药科技股份有限公司）与参比制剂诺氟沙星片（持证商：杏林制药株式会社，商品名：BACCIDAL®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂诺氟沙星胶囊和参比制剂诺氟沙星片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation norfloxacin capsules (manufacturer: Wuhan Tongji Modern Pharmaceutical Technology Co., Ltd.) and the reference preparation norfloxacin tablets (licensed manufacturer: Xinglin Pharmaceutical Co., Ltd., trade name: BACCIDAL®) in healthy subjects after oral administration in the fasting state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation norfloxacin capsules and the reference preparation norfloxacin tablets in healthy subjects.

Start Date22 Feb 2023

Sponsor / Collaborator

Wuhan Tongji Modern Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Norfloxacin

100 Translational Medicine associated with Norfloxacin

100 Patents (Medical) associated with Norfloxacin

5,521

Literatures (Medical) associated with Norfloxacin

01 May 2024·Talanta

Unveiling angular sweep total fluorescence Spectroscopy:A novel multidimensional technique for analysis of complex multi-fluorophoric systems

Article

Author: Vijayan, Anupama ; Prakash, John

Analyzing multi-fluorophoric real systems without pre-processing is challenging, often addressed with unconventional fluorescence techniques and chemometrics. In this context, we introduce a novel addition - 'Angular Sweep Total Fluorescence Spectroscopy (ASTFS),' to the arsenal of multidimensional steady-state fluorescence spectroscopic techniques. ASTFS utilizes a series of variable angle synchronous fluorescence spectra, strategically covering the fluorescence region between the first and second-order Rayleigh scattering ridges. The plot features a minimal data matrix size, avoids Rayleigh scattering signals, and incurs no blind regions. The study delves into the instrumental configurations for spectral acquisition, highlights the enhanced spectral resolution due to the band-narrowing effect, and discusses other notable features of the ASTFS plot. Further, this technique is reported to be effective in analyzing analytes in complex systems with strong background fluorescence, such as milk. The antibiotic- Norfloxacin is quantified via minimal pre-processing in milk samples and yields excellent analytical figures of merit.

01 Mar 2024·Journal of hazardous materials

Urbanization and land use regulate soil vulnerability to antibiotic contamination in urban green spaces

Article

Author: Li, Min ; Bu, Qingwei ; Wang, Xinmiao ; Yen, Haw ; Feng, Qingyu ; Yang, Lei ; Tang, Jianfeng ; Zhao, Fangkai ; Chen, Liding

The presence of antibiotics in environment is an emerging concern because of their ubiquitous occurrence, adverse eco-toxicological effects, and promotion of widespread antibiotic resistance. Urban soil, which plays a noticeable role in human health, may be a reservoir of antibiotics because of intensive human disturbance. However, little is understood about the vulnerability of soil to antibiotic contamination in urban areas and the spatial-temporal characteristics of anthropogenic and environmental pressures. In this study, we developed a framework for the dynamic assessment of soil vulnerability to antibiotic contamination in urban green spaces, combining antibiotic release, exposure, and consequence layers. According to the results, soil vulnerability risks shown obvious spatial-temporal variation in urban areas. Areas at a high risk of antibiotic contamination were usually found in urban centers with high population densities and in seasons with low temperature and vegetation coverage. Quinolones (e.g., ofloxacin and norfloxacin) were priority antibiotics that posed the highest vulnerability risks, followed by tetracyclines. We also confirmed the effectiveness of the vulnerability assessment by correlating soil vulnerability indexes and antibiotic residues in urban soils. Furthermore, urbanization- and land use-related parameters were shown to be critical in regulating soil vulnerability to antibiotic contamination based on sensitivity analysis. These findings have important implications for the prediction and mitigation of urban soil contamination with antibiotics and strategies to improve human health.

01 Mar 2024·Veterinary medicine and science

Antimicrobial susceptibility profile of oral and rectal microbiota of non‐human primate species in Ghana: A threat to human health

Article

Author: Chuma, Idrissa Shomari ; Sylverken, Augustina Angelina ; Roos, Christian ; Mfinanga, Sayoki Godfrey Mrinde ; Lubinza, Clara Clavery ; Tawiah, Patrick Ofori ; Knauf, Sascha ; Adade, Eugene

Abstract:

Background:

The potential for the transfer of zoonotic diseases, including bacteria between human and non‐human primates (NHPs), is expected to rise. It is posited that NHPs that live in close contact with humans serve as sentinels and reservoirs for antibiotic‐resistant bacteria.

Objectives:

The objective was to characterize the oral and rectal bacteria in Ghanaian NHPs and profile the antimicrobial susceptibility of the isolated bacteria.

Methods:

Oral and rectal swabs were obtained from 40 immobilized wild and captive NHPs from 7 locations in Ghana. Standard bacteriological procedures were used in the isolation, preliminary identification, automated characterization and antimicrobial susceptibility test (AST) of bacteria using the Vitek 2 Compact system.

Results:

Gram‐negative bacteria dominated isolates from the rectal swabs (n = 76, 85.4%), whereas Gram‐positive bacteria were more common in the oral swabs (n = 41, 82%). Staphylococcus haemolyticus (n = 7, 14%) was the most occurring bacterial species isolated from the oral swabs, whereas Escherichia coli (n = 32, 36%) dominated bacteria isolates from rectal swabs. Enterobacter spp. had the highest (39%) average phenotypic resistance to antimicrobials that were used for AST, whereas a trend of high resistance was recorded against norfloxacin, Ampicillin and Tetracycline in Gram‐negative bacteria. Similarly, among Gram‐positive bacteria, Staphylococcus spp. had the highest (25%) average phenotypic resistance to antimicrobials used for AST, and a trend of high resistance was recorded against penicillin G and oxacillin.

Conclusions:

This study has established that apparently healthy NHPs that live in anthropized environments in Ghana harbour zoonotic and antimicrobial resistant bacteria.

News (Medical) associated with Norfloxacin

09 Feb 2021

·www.globenewswire.com

Global Urinary Tract Infection Treatment Markets, 2020-2027 - Market for Penicillin and Combination Drugs Segment to Grow at Highest Rate

Dublin, Feb. 09, 2021 (GLOBE NEWSWIRE) -- The "Urinary Tract Infection Treatment Market Forecast to 2027 - COVID-19 Impact and Global Analysis By Drug Class, Indication, Distribution Channel, and Geography" report has been added to ResearchAndMarkets.com's offering. Market for Penicillin and Combination Drugs Segment to Grow at Highest CAGR during 2020-2027. The market is expected to reach US$ 11,614.32 million by 2027 from US$ 9,106.40 million in 2019; it is estimated to grow at a CAGR of 3.2% from 2020 to 2027. The growth of the market is attributed to the growing prevalence of urinary tract infections, aging population, and emerging computing technologies for urine diagnostics. However, the lack of product awareness in emerging countries and effects associated with medication obstruct the growth of the market to a certain extent. Based on drug class, the quinolones segment held the largest share of the market in 2019; however, the penicillin and combination segment is anticipated to register the highest CAGR of 4.5% in the market during the forecast period. The future growth of the market for quinolones is mainly ascribed to the fact that it is most commonly prescribed by physicians. Ciprofloxacin, levofloxacin, and enoxacin are among the most widely used drugs for treatment. R& D in UTI treatment is expected to offer lucrative growth opportunities to the players in the global urinary tract infection treatment market. For instance, in July 2018, Lupin received approval from the US Food and Drug Administration (FDA) for generic Nitrofurantoin capsules. It is a generic version of Macrodantin offered by Alvogen Malta Operations Ltd. It is used to treat UTI caused by Staphylococcus aureus, enterococci, etc. Further, in February 2020, a France-based pharmaceutical company announced Exblifep, a combination of a novel extended-spectrum beta-lactamase inhibitor, enmetazobactam, and cefepime. i.e., the fourth-generation cephalosporin, which achieved primary endpoints in a clinical trial for complicated UTIs. Moreover, in July 2019, Healthy.io, a smartphone camera-based solutions developer, announced an agreement with Walgreens Boots Alliance, Inc. placing Healthy.io's Dip UTI test kits in boots pharmacies throughout the UK. Additionally, in May 2020, Spero Therapeutics, Inc. announced the completion of patient enrollment in its Phase 3 clinical trial, ADAPT-PO, of tebipenem HBr to treat complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). In July 2019, the US FDA approved Recarbrio drug to treat cUTI and complicated intra-abdominal infection in adults. In June 2018, Achaogen, Inc. received the US FDA approval for ZEMDRI to treat cUTIs in adults. In November 2018, Allergan, announced the launch of the FDA accepted supplemental drug AVYCAZ to treat cUTIs and complicated intra-abdominal infections patients between the age group of 3 months to 18 years. Applying such strategic measures can be lucrative for the urinary tract infection treatment market during the forecast period. Teva Pharmaceutical Industries Ltd, Sun Pharmaceutical Industries Ltd, Mylan N.V., ALLERGAN, Pfizer Inc., Cipla Ltd, F. Hoffmann-La Roche Ltd, Shionogi Inc., Amway, and DuPont Nutrition & Biosciences are among the leading companies in the urinary tract infection treatment market. Key Topics Covered: 1. Introduction 2. Urinary Tract Infection Treatment Market - Key Takeaways 3. Research Methodology 3.1 Coverage 3.2 Secondary Research 3.3 Primary Research 4. Urinary Tract Infection Treatment Market - Market Landscape 4.1 Overview 4.2 PEST Analysis 4.3 Expert Opinion 5. Urinary Tract Infection Treatment Market - Key Market Dynamics 5.1 Market Drivers 5.1.1 Growing Urinary Tract Infections 5.1.2 Aging Population 5.1.3 Emerging Computing Technologies for Urine Diagnostics 5.2 Market Restraints 5.2.1 Associated Effects of Medication 5.3 Market Opportunities 5.3.1 R&D in UTI Treatment 5.4 Future Trends 5.4.1 Nutritional Supplement in UTI 6. Urinary Tract Infection Treatment Market - Global Analysis 6.1 Global Urinary Tract Infection Treatment Market Revenue Forecast and Analysis 6.2 Global Urinary Tract Infection Treatment Market, By Geography - Forecast and Analysis 6.3 Market Positioning of Key Players 7. Urinary Tract Infection Treatment Market Analysis - By Drug Class 7.1 Overview 7.2 Urinary Tract Infection Treatment Market Revenue Share, by Drug Class (2019 and 2027) 7.3 Penicillin and Combinations 7.3.1 Overview 7.3.2 Penicillin and Combinations: Urinary Tract Infection Treatment Market - Revenue and Forecast to 2027 (US$ Million) 7.3.3 Amoxicillin 7.3.4 Amoxicillin and Clavulanate Potassium 7.4 Quinolones 7.4.1 Overview 7.4.2 Quinolones: Urinary Tract Infection Treatment Market - Revenue and Forecast to 2027 (US$ Million) 7.4.3 Ciprofloxaxin 7.4.4 Levofloxaxin 7.4.5 Nalidixic Acid 7.4.6 Norfloxacin 7.4.7 Others 7.5 Cephalosporin 7.6 Aminoglycoside Antibiotics 7.7 Sulphonamides 7.8 Nutritional Supplements 7.8.1 Overview 7.8.2 Nutritional Supplements: Urinary Tract Infection Treatment Market - Revenue and Forecast to 2027 (US$ Million) 7.8.3 Cranberry Supplements 7.8.4 D-Mannose 7.8.5 Probiotics 7.8.6 Vitamin-C 8. Urinary Tract Infection Treatment Market Analysis - By Indication 8.1 Overview 8.2 Urinary Tract Infection Treatment Market Revenue Share, by Indication (2019 and 2027) 8.3 Complicated Urinary Tract Infections 8.4 Uncomplicated Urinary Tract Infections 9. Urinary Tract Infection Treatment Market Analysis - By Distribution Channel 9.1 Overview 9.2 Urinary Tract Infection Treatment Market Revenue Share, by Distribution Channel (2019 and 2027) 9.3 Hospital Pharmacies 9.4 Retail Pharmacies & Drug Stores 9.5 Gynaecology and Urology Clinics 9.6 Online Drug Stores 10. Urinary Tract Infection Treatment Market - Geographic Analysis 11. Impact of COVID-19 Pandemic on Global Urinary Tract Infection Treatment Market 12. Urinary Tract Infection Treatment Market-Industry Landscape Companies Mentioned Teva Pharmaceutical Industries Ltd Sun Pharmaceutical Industries Ltd Mylan N.V. ALLERGAN Pfizer Inc. Cipla Ltd F. Hoffmann-La Roche Ltd Shionogi Inc. Amway DuPont Nutrition & Biosciences For more information about this report visit CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

Collaborate

100 Deals associated with Norfloxacin

External Link

KEGG	Wiki	ATC	Drug Bank
D00210	Norfloxacin	J01MA06 S01AE02	DB01059

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Corneal Ulcer	JP	KYORIN Pharmaceutical Co., Ltd.	24 Nov 1992
Blepharitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Blepharitis	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Conjunctivitis	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Dacryocystitis	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Dacryocystitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Hordeolum	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Hordeolum	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Keratitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Gonorrhea	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Prostatitis	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Salmonella Infections	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Typhoid Fever	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Urinary Tract Infections	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Infectious Diseases	JP	KYORIN Pharmaceutical Co., Ltd.	15 Feb 1984

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cystitis	Phase 3	-	Eurofarma Laboratórios SA	01 Oct 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03584724 (CTgov)	Early Phase 1	Uveitis	49	Norflo Oro (Norflo Oro)	zwqeivdkzh(wiaowvixup) = ryfswtazgo hyqfkjmxny (buhkycdmle, pmnjalivpw - pjdfozpoyc) View more	-	28 Mar 2022
				Placebo for Norflo Oro (Placebo for Norflo Oro)	zwqeivdkzh(wiaowvixup) = ijukgfdzww hyqfkjmxny (buhkycdmle, tcirskxigk - sdwdabzabk) View more
EASL2020	Not Applicable	Spontaneous bacterial peritonitis	1,626	Norfloxacin	vpqllyazsh(duluqvhajn) = qzablthxpy sdwgubajcq (wxzwreuezv ) View more	Negative	27 Aug 2020
				Placebo	-
NCT01037959 (Pubmed \| Gastroenterology)	Phase 3	Fibrosis	291	Norfloxacin 400 mg	hxkxmrfuap(ukekqzbbdr) = vctieejjji abakxbvrfl (kxcaiynbvw )	-	01 Dec 2018
				Placebo	hxkxmrfuap(ukekqzbbdr) = mzywhedkpd abakxbvrfl (kxcaiynbvw )
ARVO2002	Not Applicable	-	-	Levofloxacin 0.5%	lorzxtthge(kpcfovppkp) = amxwceefki tmkajsiudb (yiqpdmwzag, 3.53)	-	01 Dec 2002
				Norfloxacin 0.3%	lorzxtthge(kpcfovppkp) = ccrltobmzf tmkajsiudb (yiqpdmwzag, 1.18)
NCT04159870 (Pubmed \| Gastroenterology)	Phase 3	Gastrointestinal Hemorrhage	119	Norfloxacin	dwcqoouwla(rbhtccwjjq) = ulzstvauwp dzoiglytvt (xunrewllvz ) View more	-	01 Oct 1992
				Norfloxacin (Control)	kjefufsaao(mplpbyrobr) = jjafbnydsd swwzzesaec (gpfvbybqig ) View more

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