主要目的：在健康受试者体内，分别在空腹和餐后状态下，以安徽环球药业股份有限公司持有的盐酸安妥沙星片（规格：0.1 g（以C18H21FN4O4 计）；商品名：优朋®）为参比制剂，研究仁合益康集团有限公司持有的盐酸安妥沙星片（规格：0.1 g（以C18H21FN4O4 计）；受试制剂）的药代动力学，评价受试制剂与参比制剂是否具有生物等效性。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]

Primary objective: To study the pharmacokinetics of Antofloxacin Hydrochloride Tablets (Specification: 0.1 g (in terms of C18H21FN4O4); Test Preparation) held by Renhe Yikang Group Co., Ltd. in healthy subjects in fasting and postprandial states, using Antofloxacin Hydrochloride Tablets (Specification: 0.1 g (in terms of C18H21FN4O4); Trade Name: Youpeng®) held by Anhui Huanqiu Pharmaceutical Co., Ltd. as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date29 Nov 2023

Sponsor / Collaborator

Renhe Yikang Group Co., Ltd.

ChiCTR2200056931 / CompletedPhase 1IIT

The efficacy and safety of Saccharomyces boulardii in addition to antofloxacin-based bismuth quadruple therapy for Helicobacter pylori eradication: A randomized, single center trial

Start Date01 Jan 2020

Sponsor / Collaborator-

CTR20160240 / RecruitingPhase 2

盐酸安妥沙星注射液治疗社区获得性肺炎的多中心、随机、双盲、阳性药平行对照Ⅱ期临床研究

[Translation] A multicenter, randomized, double-blind, positive-drug parallel-controlled phase II clinical study of antofloxacin hydrochloride injection in the treatment of community-acquired pneumonia

本项试验以盐酸左氧氟沙星注射液为对照药，通过多中心、随机、双盲、平行对照临床试验的方法初步评价盐酸安妥沙星注射液400mg QD给药方案治疗社区获得性肺炎的安全性和有效性，为Ⅲ期临床试验方案设计提供依据。

[Translation]

This trial used levofloxacin hydrochloride injection as the control drug, and preliminarily evaluated the safety and efficacy of 400 mg QD dosing regimen of levofloxacin hydrochloride injection in the treatment of community-acquired pneumonia through a multicenter, randomized, double-blind, parallel-controlled clinical trial, providing a basis for the design of the Phase III clinical trial.

Start Date09 Jul 2016

Sponsor / Collaborator

Anhui Hongxiang Pharmaceutical Technology Co., Ltd.

[+1]

100 Clinical Results associated with Antofloxacin Hydrochloride

100 Translational Medicine associated with Antofloxacin Hydrochloride

100 Patents (Medical) associated with Antofloxacin Hydrochloride

Literatures (Medical) associated with Antofloxacin Hydrochloride

01 Jan 2023·Clinics and Research in Hepatology and Gastroenterology

Comparison of 10 and 14 days of antofloxacin-based versus 14 days of clarithromycin-based bismuth quadruple therapy for Helicobacter pylori eradication: A randomized trial

Article

Author: Wang, Xiao-Ling ; Li, Da-Zhou ; He, Xiao-Jian ; Li, Dong-Liang ; Liu, Gang ; Wang, Wen ; Huang, Xiao-Yan

OBJECTIVEOur team previously reported the use of antofloxacin-based bismuth quadruple therapy for the eradication of Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of 10 and 14 days of antofloxacin-based versus 14 days of clarithromycin-based bismuth quadruple therapy in the first-line treatment for H. pylori infection.METHODS1174 patients with H. pylori infection were randomized into three groups: 10-days and 14-days antofloxacin (ANT10 and ANT14) groups who received 10 and 14 days of antofloxacin-based bismuth quadruple therapy (colloidal bismuth pectin 200 mg t.i.d., esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and antofloxacin 200 mg q.d.), 14-days clarithromycin (CLA14) group who received 14 days of clarithromycin-based bismuth quadruple therapy (colloidal bismuth pectin 200 mg t.i.d., esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d.). Eradication rate, antibiotic resistance and adverse events were analyzed.RESULTSThe intention-to-treat (ITT) and per-protocol (PP) analyses have showed statistically different eradication rates between ANT14 group and ANT10 group (ITT p = 0.001; PP p < 0.001), but no statistical difference between ANT10 group and CLA14 group (ITT p = 0.340; PP p = 0.092). Treatment regimen, drug resistance and therapy duration were important clinical factors related to H. pylori eradication rates in multivariate logistic analysis. Longer durations had significantly higher eradication rates in patients with antibiotic-resistant strains or antibiotic-susceptible strains. The incidences of nausea and bitter taste were significantly higher in CLA group compared with ANT group (p = 0.002 for nausea; p = 0.002 for bitter taste). The ANT10 and ANT14 group had similar adverse event rates of gastrointestinal reactions.CONCLUSIONThe study showed that the H. pylori eradication rate with ANT14 therapy was higher than that with ANT10 and CLA14 therapy without significantly increasing the rates of adverse event. 14 days of antofloxacin-based bismuth quadruple therapy may be a more effective way as the first-line treatment for H. pylori infection.

01 Jan 2023·Therapeutic Advances in Gastroenterology

The efficacy and safety of Saccharomyces boulardii in addition to antofloxacin-based bismuth quadruple therapy for Helicobacter pylori eradication: a single-center, prospective randomized-control study

Article

Author: Wang, Wen ; Huang, Xiao-Yan ; Zeng, Xiang-Peng ; Liu, Gang ; He, Xiao-Jian ; Sun, Dong-Jie ; Lin, Hai-Lan ; Li, Da-Zhou ; Li, Dong-Liang ; Wang, Xiao-Ling

Background: We previously reported that antofloxacin-based bismuth quadruple therapy was safe and effective for Helicobacter pylori ( H. pylori) eradication. It is not clear whether the addition of Saccharomyces boulardii ( S. boulardii) to antofloxacin-based quadruple therapy can improve the eradication rate of H. pylori and reduce adverse events. Objective: To investigate the effect of adding S. boulardii to antofloxacin-based quadruple therapy on the eradication rate of H. pylori and the adverse events. Design: Single-center, prospective randomized controlled study. Methods: A total of 172 patients with H. pylori infection were randomly assigned to the test and control groups. Patients in the control group ( n = 86) received antofloxacin-based bismuth quadruple therapy for 14 days. On this basis, cases in the test group ( n = 86) received S. boulardii 500 mg b.i.d. The eradication rate of H. pylori and adverse events were observed 4 weeks after the treatment. Results: There were no statistically significant differences in the eradication rates of H. pylori and frequency of diarrhea between the test group and control group ( p > 0.05). The duration of diarrhea in the test group was significantly shorter than in the control group ( p < 0.001). In addition, the two groups exhibited similar adverse event rates for epigastric pain, abdominal distention, dizzy, vomiting, and rash ( p > 0.05). The severity of adverse reactions was similar between the two groups ( p > 0.05), and most of them had mild adverse events. Conclusion: Although the addition of S. boulardii to antofloxacin-based quadruple therapy could not improve the eradication rate of H. pylori, it could shorten the time of antibiotic-associated diarrhea and reduce the incidence of diarrhea. Trial registration number: ChiCTR2200056931.

01 Jan 2022·Digestive Diseases and SciencesQ3 · MEDICINE

Efficacy and Safety of Antofloxacin-Based Triple Therapy for Helicobacter pylori Eradication Failure in China

Q3 · MEDICINE

Article

Author: Liu, Gang ; Li, Da-Zhou ; He, Xiao-Jian ; Wang, Wen ; Jiang, Chuan-Shen ; Zeng, Xiang-Peng

AIMSQuinolone-containing triple therapy has been considered as the second-line therapy for eradication of Helicobacter pylori (H. pylori). At present, there are no data to show the efficacy and safety of antofloxacin-based rescue therapy for the eradication of H. pylori, and this pilot clinical trial was designed.METHODSA total of 196 patients who failed H. pylori eradication using the clarithromycin-based or metronidazole-based triple or bismuth quadruple therapy were randomly allocated to one of the following rescue eradication therapy groups: AEA group (antofloxacin 200 mg once daily, esomeprazole 20 mg + amoxicillin 1000 mg twice daily) for 14 days, or LEA group (levofloxacin 500 mg once daily, esomeprazole 20 mg + amoxicillin 1000 mg twice daily) for 14 days. The minimal inhibitory concentrations were tested by the E-test method. The gyrA mutation was analyzed by sequencing. Follow-up ^13/14C-urea breath test was examined at 1 month after discontinuation.RESULTSA total of 178 eligible patients were included in this study. The eradication rate was significantly higher in AEA group than in LEA group according to both ITT (87.6% vs. 68.5%; P = 0.002) and PP analyses (90.7% vs. 70.1%; P = 0.001). ITT analyses indicated that the eradication rate was significantly higher in AEA group than in LEA group with Asn87 mutation (78.9% vs. 31.3%; P = 0.005) and levofloxacin-resistant strains (76.9% vs. 44.2%; P = 0.003). Two groups exhibited similar adverse event rates (AEA 14.6% vs. LEA 20.2%, P = 0.323).CONCLUSIONSThe findings showed that antofloxacin may be a promising candidate in rescue therapy for H. pylori eradication failure in China.

100 Deals associated with Antofloxacin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J01	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bacterial Infections	CN	Anhui Global Pharmaceutical Co., Ltd.	15 Apr 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Community Acquired Pneumonia	Phase 2	CN	Anhui Global Pharmaceutical Co., Ltd.	09 Jul 2016
Pyelonephritis	Phase 2	CN	Anhui Global Pharmaceutical Co., Ltd.	23 May 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis