[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of fasting and fed oral administration of STBN in healthy Chinese subjects

主要研究目的研究空腹和餐后状态下单次口服受试制剂头孢地尼干混悬剂（规格：250mg/5ml，广东万泰科创药业有限公司提供）与参比制剂头孢地尼干混悬剂（规格：250mg/5ml，持证商：Aurobindo Pharma Limited），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢地尼干混悬剂和参比制剂头孢地尼干混悬剂后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation cefdinir dry suspension (specification: 250mg/5ml, provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation cefdinir dry suspension (specification: 250mg/5ml, licensee: Aurobindo Pharma Limited) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after fasting and fed oral administration. Secondary study objectives To evaluate the safety of the test preparation cefdinir dry suspension and the reference preparation cefdinir dry suspension after a single oral administration in the fasting and fed state in healthy Chinese subjects.

Start Date29 Sep 2024

Sponsor / Collaborator

Guang Dong Wan Tai Ke Chuang Yao Ye You Xian Gong Si

CTR20242859

/ CompletedNot Applicable

头孢地尼干混悬剂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/餐后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/fed bioequivalence trial of cefdinir dry suspension 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，分别比较在空腹/餐后状态下口服受试制剂头孢地尼干混悬剂（生产厂家：苏州第三制药厂有限责任公司）与参比制剂头孢地尼干混悬剂（持证商：Aurobindo Pharma Limited）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。

[Translation]

Main objective: To compare the pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation cefdinir dry suspension (manufacturer: Suzhou Third Pharmaceutical Factory Co., Ltd.) and the reference preparation cefdinir dry suspension (licensed manufacturer: Aurobindo Pharma Limited) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.

Start Date10 Sep 2024

Sponsor / Collaborator

Suzhou No.3 Pharmaceutical Factory Co., Ltd.

CTR20241322

/ CompletedNot Applicable

中国健康受试者空腹和餐后单次口服头孢地尼干混悬剂的随机、开放、两序列、两周期、双交叉设计的生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of cefdinir dry suspension in Chinese healthy volunteers on an empty stomach or after a meal

主要研究目的研究空腹和餐后状态下单次口服受试制剂头孢地尼干混悬剂（规格：250mg/5ml，广东金城金素制药有限公司提供）与参比制剂头孢地尼干混悬剂（规格：250mg/5ml，持证商：Aurobindo Pharma Limited），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢地尼干混悬剂和参比制剂头孢地尼干混悬剂后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of a single oral dose of the test preparation cefdinir dry suspension (specification: 250mg/5ml, provided by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference preparation cefdinir dry suspension (specification: 250mg/5ml, licensee: Aurobindo Pharma Limited) in healthy adult subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and fed conditions. Secondary study objectives To evaluate the safety of a single oral dose of the test preparation cefdinir dry suspension and the reference preparation cefdinir dry suspension in healthy Chinese subjects under fasting and fed conditions.

Start Date06 May 2024

Sponsor / Collaborator

Guangdong Jincheng Jinsu Pharmaceutical Co Ltd.

100 Clinical Results associated with Acute maxillary sinusitis

100 Translational Medicine associated with Acute maxillary sinusitis

0 Patents (Medical) associated with Acute maxillary sinusitis

399

Literatures (Medical) associated with Acute maxillary sinusitis

17 Jul 2024·Cureus

Exploring the Therapeutic Potential of High Dose Co-amoxiclav (1 gm) in Different Clinical Conditions: A Review

Review

Author: Jena, Debasis ; Pal, Amitrajit ; Pawar, Dattatray ; Sharma, Akhilesh ; Kanti Ghosh, Tushar

Amoxicillin/clavulanate (co-amoxiclav) is a widely used antibiotic in community healthcare settings, combining amoxicillin and clavulanate potassium to combat β-lactamase-producing bacteria. Despite its extensive use, limited pharmacokinetic/pharmacodynamic data support current dosing guidelines. This review explores the significance of high-dose co-amoxiclav (875 mg/125 mg) in treating various infections amidst rising antibiotic resistance. A comprehensive narrative literature review was conducted using MEDLINE, PubMed, and Google Scholar, focusing on co-amoxiclav 875 mg/125 mg from 1992 to 2024. Keywords included "Co-amoxiclav 875mg/125mg," "amoxicillin 875mg," "Co-amoxiclav dosing," "pharmacology," "PK," and "safety." Studies on non-safety aspects, those on cost-effectiveness, non-English articles, and those without full-text access were excluded. Clinical efficacy studies demonstrate the effectiveness of co-amoxiclav (875 mg/125 mg) in treating conditions such as cutaneous actinomycosis, actinomycetoma, lower respiratory tract infections, acute bacterial maxillary sinusitis, and community-acquired pneumonia. Comparative studies reveal similar or superior efficacy of co-amoxiclav (875 mg/125 mg) compared to other dosing regimens and antibiotics such as clindamycin, cefaclor, cefuroxime, and ciprofloxacin. Safety and tolerability assessments indicate that co-amoxiclav is generally well-tolerated, with common mild-to-moderate gastrointestinal side effects. In summary, co-amoxiclav 1 gm remains a crucial antibiotic with optimized dosing regimens enhancing clinical outcomes while addressing resistance challenges.

01 Jan 2024·Russian Bulletin of Otorhinolaryngology

Optimization of the puncture treatment method for acute bacterial maxillary sinusitis

Article

Author: Kishinevskii, A E ; Artemyeva-Karelova, A V ; Bolgar, A Ya ; Ogorodnikov, D S ; Timofeeva, M G ; Tovmasyan, A S ; Kryukov, A I ; Lapchenko, A A

OBJECTIVEOptimization of the method of puncture treatment of acute bacterial maxillary sinusitis (ABMS) through the development of original devices for drainage of the maxillary sinus (MS).MATERIAL AND METHODSRegistration and comparative analysis of the results of puncture methods of treatment of 120 patients with ABMS using developed new original devices for drainage of MS with one channels and with two channels in comparison with the Kulikovsky's needle (KN) was carried out. Based on the results of the analysis, the effectiveness of the original devices was assessed. During the clinical study, patients were divided into two groups: in group I, patients underwent of the MS puncture using KN, in group II, using original devices. Groups I and II, depending on the absence or presence of a block of the natural anastomosis MS, was divided into subgroups A and B, respectively. After puncture of the MS, the pain syndrome was assessed by patients using Visual Analogue Scale (VAS) and by doctors - using Touch Visual Pain (TVP) scale.RESULTSOur study showed that when puncturing the upper jaw with an original needle with one channels and with two channels, compared with the use of KN, there is a decrease in pain (the average VAS score was 1.5±0.3 and 1.7±0.3 points, respectively; the average TVP scale score was 0.9±0.2 and 1.8±0.3 points, respectively, the difference is significant, p≤0.05). Patients of subgroup IB were manipulated with two KN, patients of subgroup IIB manipulated using the original device with two channels without an additional needle (the average VAS score was 3.0±0.4 and 1.3±0.3 points, respectively; the average TVP scale score was 2.7±0.4 and 1.0±0.2 points, respectively, the difference is significant, p≤0.05). The doctors also assessed the devices used for puncture of the upper jaw. As a result of the study, the high efficiency and safety of using new original devices was established.

01 Aug 2023·Ear, Nose & Throat JournalQ4 · MEDICINE

Safety of a New Sinus Irrigation Device in Rhinosinusitis: A Pilot Study

Q4 · MEDICINE

ArticleOA

Author: Grinblat, Golda ; Levine, Howard ; Shochat, Isaac ; Braverman, Itzhak

Background:Puncture and lavage of the paranasal sinuses, previously the primary treatment for unresponsive acute bacterial rhinosinusitis before surgery, has been abandoned due to procedural discomfort and advancements in antibiotic efficacy and endoscopic surgery. The rise in antibiotic-resistant bacteria has renewed the interest in minimally invasive sinus lavage to both avoid aggressive surgical interventions and identify appropriate antibiotic therapy. In this article, we describe the safety and feasibility of a new device in human patients and evaluate its efficacy as a treatment before the traditional sinus surgery in acute rhinosinusitis.Methods:The device with its seeker-shaped guiding tube and rotating wire can enter the sinus cavity through the natural ostium, pulverize the inspissated mucus, and enable lavage and culture sampling without the need for sinus puncturing. It was tested in 6 patients with chronic sinusitis under general anesthesia during endoscopic sinus surgery and in additional 10 patients with maxillary acute bacterial rhinosinusitis in outpatient settings under local anesthesia.Results:The device enabled rapid, efficient, and atraumatic insertion of the wire into the occluded sinuses. The rotating wire permitted pulverization of the thick mucus, which enabled irrigation without mucosal damage or adverse events. Overall, 9 of 10 patients with acute bacterial rhinosinusitis demonstrated remarkable improvements and were discharged the following day with no acute symptoms. The visual analog scale score for pain dropped from 8.9 to 0.4. The remaining one patient underwent endoscopic sinus surgery subsequently. None of the patients treated during endoscopic sinus surgery developed any adverse events.

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