An open-label, balanced, randomized, three-treatment, four-sequence, four-period, single dose, partial replicate, crossover, oral bioequivalence study of Test product 1 (T1), Olsalazine sodium 250 mg (250 mg x 2) capsules (Zuventus Healthcare Limited, India) and Test product 2 (T2), Olsalazine sodium 500 mg (500 mg x 1) capsules (Zuventus Healthcare Limited, India) with Reference product (R), Olsalazine Sodium 250 mg (250 mg x 2) capsules (Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom) in healthy, adult, human subjects under fasting conditions. - NIL

Start Date31 Mar 2025

Sponsor / Collaborator

Zuventus Healthcare Ltd.

CTRI/2024/10/075314

/ RecruitingPhase 3

A multi-centric, open-label, comparative, randomized, phase 3 trial to evaluate the efficacy and safety of Aviptadil as an add-on treatment to the Standard of Care in acute respiratory distress syndrome. - NIL

Start Date26 Oct 2024

Sponsor / Collaborator

Zuventus Healthcare Ltd.

[+1]

CTRI/2024/03/064100

/ RecruitingPhase 4

A multicentric, open label study to evaluate the safety and efficacy of fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets in the management of Stage II hypertension. - NIL

Start Date20 Mar 2024

Sponsor / Collaborator

Zuventus Healthcare Ltd.

100 Clinical Results associated with Zuventus Healthcare Ltd.

0 Patents (Medical) associated with Zuventus Healthcare Ltd.

Literatures (Medical) associated with Zuventus Healthcare Ltd.

04 Mar 2025·Asian Journal of Pharmaceutical Analysis

Development and Validation of related Substances method for Deflazacort Suspension by High Performance Liquid Chromatography using AQbD Approach

Author: Kinage, Krishna ; Jadhav, Balasaheb ; Khopade, Sachin ; Gharge, Vikram ; Bang, Pranav

The stability-indicating method for Deflazacort Suspension was developed using the Analytical Quality by Design (AQbD) approach, focusing on process control and understanding. A multilevel factorial design was used to optimize the gradient mode's time and mobile phase ratio. Sophisticated software like Design Expert and Minitab aided in chromatographic condition optimization. The method utilizes a Zorbax Eclipse XDB C18 column (150mm x 4.6mm, 5µm particle size), with a flow rate of 1.0 mL/min, and monitoring the analyte with a UV/PDA detector at of 245nm wavelength known for its reliability. It employs two mobile phases: A, consisting of Water, Tetrahydrofuran, and Acetonitrile (91:3:6, v/v/v), and B, comprising Water, Tetrahydrofuran, Acetonitrile, and Methanol (4:2:74:20, v/v/v/v). Statistical analysis confirms the importance of these components in achieving effective separation and detecting related substances. The validation of method was done as per ICH guidelines. Linearity, specificity, Limit of Detection (LOD), Limit of Quantification (LOQ), precision, accuracy, solution stability, and robustness parameters were validated. The method was validated to ensure reliability and accuracy, demonstrating linearity from 0.02 to 1.2ppm with a correlation coefficient (r2 > 0.99) at 245nm. This confirms the method's ability to precisely quantify related substances in Deflazacort Suspension. The stability of Deflazacort Oral Suspension was rigorously assessed, including a forced degradation study. Critical system suitability parameters, tailing factor, and theoretical plate, met acceptable limits, confirming the method's efficiency and resolution. Successful separation of degradation peaks from each other and the main peak was achieved during the study. The method's robustness was confirmed with variations under 2%, ensuring consistent and reproducible results despite minor changes in conditions. Peak purity analysis showed no co-eluting peaks, confirming the method's specificity. These findings validate the stability-indicating nature of the chromatographic method for Deflazacort Oral Suspension analysis, ensuring its reliability for quality control.

30 Dec 2024·Indian Journal of Critical Care Medicine

Clinical Efficacy and Safety of Ibutilide in Cardioversion of Atrial Fibrillation or Flutter in Indian Patients: A Multicenter Study

Article

Author: Navale, Sanjaykumar ; Chaudhary, Janaki ; Dewan, Bhupesh ; Shinde, Siddheshwar

Aim and backgroundTo assess the efficacy and safety of Ibutilide infusion for cardioversion of atrial fibrillation (AF) or flutter (AFL) to sinus rhythm.Materials and methodsThis open-label, multicenter phase IV study was conducted at six sites across India. The study enrolled 120 patients (108 with AF, 12 with AFL), each receiving up to two, 10-minute intravenous doses of 1.0 mg Ibutilide. The primary endpoints were the proportion of patients achieving cardioversion and the mean time taken to achieve cardioversion. Secondary endpoints included the proportion of patients maintaining sinus rhythm at 24 hours and the incidence of adverse events.ResultsThe cardioversion rate at 4 hours post-Ibutilide infusion among 120 patients was 65.83% (n = 79), with an average conversion time of 35.12 ± 36.71 minutes. At 24 hours, 85 patients (70.8%) had successful cardioversion, with a mean time of 107.24 minutes. The majority of patients (71.76%) had achieved cardioversion within 30 minutes. Of the 85 patients who achieved successful conversion, 82 (68.3%) maintained sinus rhythm at 24 hours. A total of 66 patients (55%) achieved cardioversion with the first bolus whereas 19 (15.8%) needed a second bolus. Atrial fibrillation patients had a higher conversion rate (75%) compared to AFL patients (33%). A total of 10 adverse events were recorded in eight patients (6.67%), including nausea, headache, palpitations, and bradycardia. Three severe cardiac events, one case of ventricular tachycardia, and two of tachycardia necessitated discontinuation of Ibutilide. No fatalities or serious adverse events (SAE) were reported.ConclusionIbutilide was found to be effective and well-tolerated for rapid restoration of sinus rhythm in patients with AF or AFL.Clinical Trial Registry of IndiaCTRI/2018/01/011248.How to cite this articleDewan B, Navale S, Shinde S, Chaudhary J. Clinical Efficacy and Safety of Ibutilide in Cardioversion of Atrial Fibrillation or Flutter in Indian Patients: A Multicenter Study. Indian J Crit Care Med 2025;29(1):45-51.

01 Jan 2024·BIO Integration

Stability Indicating RP-HPLC Method for the Estimation of Impurities in Esomeprazole Gastro-Resistant Tablets by AQbD Approach

Author: Dighe, Vitthal ; Kakade, Sushma ; Bhange, Shubham ; Gadhe, Anil ; Gharge, Vikram ; Jadhav, Balasaheb ; Mohite, Vikas

AbstractBackground: Esomeprazole (ESO) gastro-resistant tablets (40 mg) are sold under the brand name, Zosa, which effectively manages conditions associated with the overproduction of gastric acid, including peptic ulcer disease and Zollinger-Ellison syndrome. The present study quantifies impurities in esomeprazole using advanced analytical techniques known as analytical quality by design with high-performance liquid chromatography.Methods: Buffer selection (pH 7.6) and mobile phase composition (75:25 v/v) were optimized utilizing a YMC C18 column (150 mm × 4.6 mm; particle size, 3 μm) with a flow rate of 1.0 mL/min. The analyte was monitored with a UV/PDA detector at a wavelength of 280 nm. The stability-indicating nature of the method was confirmed based on forced degradation studies. The method validation was performed per ICH guidelines. Linearity, specificity, limit of detection, limit of quantification, precision, accuracy, solution stability, and robustness parameters were validated.Results: All validation parameters were within an acceptable range. Excellent linearity with correlation coefficient values > 0.99 was achieved across the quantification limit. The solution stability study demonstrated no significant increase in percent impurity over a 24-h period. Analytical quality by design was instrumental in defining the design range for buffer pH and mobile phase composition, ensuring robust method performance. It was confirmed that 75% buffer solution, 25% acetonitrile, and pH 7.6 were the ideal conditions for determination of ESO impurities.Conclusion: The validated method provides a reliable tool for accurately quantifying impurities in ESO tablet formulations.

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100 Translational Medicine associated with Zuventus Healthcare Ltd.

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