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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

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

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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.

International Journal of Pharma and Bio Sciences

Teneligliptin – The newest DPP4 inhibitor

作者: Chandalia, H. B. ; Yadav, Pramila ; Kiran, Mayuresh

A review.Teneligliptin is the newest DPP4 inhibitor approved by the regulatory authority for the treatment of Diabetes mellitus.Teneligliptin [TEN20], is approved in Japan, India, Korea, Argentina and currently undergoing Phase I trials in the USA and Phase II trials in Europe for the treatment of T2DM.Teneligliptin scores over other 'gliptins' in being more economical and with better efficacy to control blood glucose and HbA1C levels.Teneligliptin addnl. offers other pharmacol. advantages like longer half-life, lesser IC50 value, tight and extensive binding to the DPP4 enzyme.Teneligliptin has been studies extensively for its safety and efficacy in various clin. trials conducted internationally.Teneligliptin has sufficient and adequate clin. data to prove itself as monotherapy and combination therapy with other Anti-Diabetic agents.No dose adjustment is requires in renal failure but certain studies included dose reduction in mild to moderate hepatic failure.Certain clin. trials have demonstrated cardio-protective effects of teneligliptin in T2DM patients with increase in serum adiponectin levels.It is safe and well tolerated, also weight neutral, have low risk of Hypoglycemia and are equally efficacious with rare side effects compared to other gliptins.This review article comprehensively documents the available clin. and pharmacol. data for Teneligliptin in the treatment of Diabetes mellitus.

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

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