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.

CTRI/2023/06/054295

/ CompletedNot Applicable

An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover, oral bioequivalence study of Test Product, Edoxaban 60 mg film-coated tablets (Zuventus Healthcare Limited, India) with Reference Product, Lixiana (Edoxaban) 60mg film coated tablets (Daiichi Sankyo Europe GmbH, 81366 Munich, Germany) in healthy, adult, human subjects under fasting conditions. - Nil

Start Date29 Jun 2023

Sponsor / Collaborator

Zuventus Healthcare Ltd.

100 Clinical Results associated with Zuventus Healthcare Ltd.

0 Patents (Medical) associated with Zuventus Healthcare Ltd.

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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 Oct 2023·Indian Journal of Tuberculosis

Aviptadil: A promising treatment option for acute respiratory distress syndrome

Letter

Author: Jaychandra, A ; Vora, Agam ; Singh, B P ; Kandi, Subhankar ; Behera, D ; Najib, Rayees ; Arora, V K ; Dewan, Bhupesh ; Koul, Parvaiz ; Ahmad, Sadiq ; Kar, Arindam ; Samaria, J K ; Katiyar, S K ; Mehta, Parthiv ; Najeeb, Rukhsana ; Nazir Shah, Naveed ; Faisal, Mir ; Jain, N K

01 Jan 2015·Indian Journal of Pharmaceutical SciencesQ4 · MEDICINE

Design, development and optimization of s (-) Atenolol floating sustained release matrix tablets using surface response methodology

Q4 · MEDICINE

Article

Author: Gharge, V S ; Gunjal, P T ; Shah, M N ; Gurjar, M K ; Pimple, S V ; Shinde, M B

The objective of this present investigation was to develop and formulate floating sustained release matrix tablets of s (-) atenolol, by using different polymer combinations and filler, to optimize by using surface response methodology for different drug release variables and to evaluate the drug release pattern of the optimized product. Floating sustained release matrix tablets of various combinations were prepared with cellulose-based polymers: Hydroxypropyl methylcellulose, sodium bicarbonate as a gas generating agent, polyvinyl pyrrolidone as a binder and lactose monohydrate as filler. The 3(2) full factorial design was employed to investigate the effect of formulation variables on different properties of tablets applicable to floating lag time, buoyancy time, % drug release in 1 and 6 h (D1 h,D6 h) and time required to 90% drug release (t90%). Significance of result was analyzed using analysis of non variance and P < 0.05 was considered statistically significant. S (-) atenolol floating sustained release matrix tablets followed the Higuchi drug release kinetics that indicates the release of drug follows anomalous (non-Fickian) diffusion mechanism. The developed floating sustained release matrix tablet of improved efficacy can perform therapeutically better than a conventional tablet.

100 Deals associated with Zuventus Healthcare Ltd.

100 Translational Medicine associated with Zuventus Healthcare Ltd.

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