Delving into the Latest Updates on Centaur Pharmaceuticals Pvt Ltd. with Synapse

A multicenter, randomized, double-blind, active-control phase III clinical trial of WOXheal® [Diperoxochloric acid] topical solution in the treatment of pressure ulcers – in comparison with the active-control 0.9% sodium chloride topical solution in addition to standard of care - NIL

开始日期2024-06-07

申办/合作机构

Centaur Pharmaceuticals Pvt Ltd.

CTRI/2024/04/066196 / Not yet recruitingN/A

An open-label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover bioequivalence study of Propiomazine Tablets 25 mg [Test] of Centaur Pharmaceuticals Pvt. Ltd. India with Propavan® 25 mg (Propiomazine Tablets 25 mg) [Reference] of Sanofi-aventis AB, Stockholm, Sweden, in healthy, adult, human Subjects under fasting conditions. - NIL

开始日期2024-05-02

申办/合作机构

Centaur Pharmaceuticals Pvt Ltd.

CTRI/2023/06/054253 / Recruiting临床3期

A multicenter, randomized, double-blind, active-control phase III clinical trial of WOXheal® [Diperoxochloric acid] topical solution in the treatment of chronic venous leg ulcer – in comparison with the active-control 0.9% sodium chloride topical solution in addition to standard of care.

开始日期2023-07-03

申办/合作机构

Centaur Pharmaceuticals Pvt Ltd.

100 项与 Centaur Pharmaceuticals Pvt Ltd. 相关的临床结果

登录后查看更多信息

0 项与 Centaur Pharmaceuticals Pvt Ltd. 相关的专利（医药）

登录后查看更多信息

12

项与 Centaur Pharmaceuticals Pvt Ltd. 相关的文献（医药）

2023-01-01·Dissolution Technologies

Dissolution Method Development for Regulatory Approval: A Comprehensive Review and Case Study

作者: Parshuramkar, Pramod ; Kashyap, Pranita ; Khobragade, Deepak

In vitro dissolution testing is an important tool for any oral drug product.It is useful for product development and to ensure the in vivo performance of drug products throughout their com. life without conducting clin. or bioequivalence studies after regulatory approval.It also plays a role in maintaining batch-to-batch consistency, providing quality assurance, supporting biowaiver and post-approval changes, etc.Guidelines from regulatory agencies provide expectations about the dissolution method and acceptance criteria; however, pharmaceutical manufacturers may fail to comply with the requirements or the expectations of the agencies, resulting in dissolution deficiencies.Furthermore, updates in dissolution testing may not be effectively communicated to non-industry scientists who are involved in dissolution or drug delivery research.This article provides a comprehensive review of the current American and European regulatory guidance for solid oral dosage forms followed by a case study to demonstrate how a dissolution method should be developed, which can be used as a framework for any drug product.

2017-04-01·World Journal of Pharmaceutical Research

SAFETY AND EFFICACY OF A COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND FEXOFENADINE IN ADULT PATIENTS OF COMMON COLD AND ALLERGIC RHINITIS: PHASE IV STUDY

作者: Pawaskar, Lalit Jeevan ; Kiran, Mayuresh Dilip

Introduction: Common cold and allergic rhinitis both are most commonly encountered diseases in clin. practises in India.Though self-limiting, it accounts for major loss of school and work days.Symptomatic therapy is often used to treat the symptoms.Combination of analgesic/anti-inflammatory/antipyretic, anti-histaminic and nasal decongestant is popular in the treatment of common cold and allergic rhinitis.This Phase IV study evaluated the efficacy and safety of one such combination of Paracetamol, Phenylephrine and Fexofenadine in treatment of common cold and allergic rhinitis.Materials and Methods: Of total 189 enrolled patients, 154 patients completed the study.Efficacy assessment was made by reduction in Total Symptom Score and four point Likert-type scales.Safety assessment was made by analyzing the adverse events through the study.Results: Reduction in mean TSS was done from 6.90 (baseline) to 3.42 (day 3) to 0.88 (day 5).Two points were reduced in Likert-type symptom scale from Severe to Mild in 3 days.Nearly all the patients had >50% reduction in their total symptom score at all visit and majority of patients had complete relief from the symptoms at visit 3.Four episodes of adverse events occurred and all of them were of mild intensity.Conclusion: A combination of Paracetamol, Phenylephrine and Fexofenadine is safe and effective in the treatment of common cold and allergic rhinitis.

European Journal of Biomedical and Pharmaceutical Sciences

Post-marketing surveillance study to evaluate the safety and efficacy of zinc gluconate in paediatric patients of diarrhea

作者: Waghambare, Pramita ; Pawaskar, Lalit ; Sheikh, Shaheen ; Kiran, Mayuresh

Diarrhea is characterised by loose, watery tools, nausea, stomach cramps, pains and other symptoms.Zinc supplementation is considered to be efficacious to minimise the frequency and severity of diarrhea.Zinc has been recommended for the treatment of diarrhea by the WHO and the UNICEF since 2004.If Zinc is paired with oral rehydration solution (ORS) and continued feeding, diarrheal morbidity and mortality can be minimised.This study was conducted to determine the efficacy and safety for Zinc Gluconate equivalent to elemental Zinc 20 mg per 5ml for the treatment of diarrhea in paediatrics in Indian population.A total 180 trial subjects were enrolled for the study.The study was conducted for the duration of 14 days in which the efficacy was analyzed till day 5 as normally the diarrhea gets managed within 5 days and the safety was analyzed till day 14.The improvement in stool consistency and the decrease in average stool frequency were used to determine efficacy.To evaluate safety, the occurrence and severity of the reported adverse events were measured.A 166 trial subjects completed the study.The average stool frequency was 8.73 on day 1 reduced to 4.19 on day 3 and further reduced to 1.89 on day 5.During the study improvement in stool consistency was also observedAdverse events reported by trial subjects were of non-serious and expected nature.Zinc Gluconate was found to be efficacious and safe for the treatment of diarrhea when given along with the ORS.

100 项与 Centaur Pharmaceuticals Pvt Ltd. 相关的药物交易

登录后查看更多信息

100 项与 Centaur Pharmaceuticals Pvt Ltd. 相关的转化医学

登录后查看更多信息