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Overview

A multicenter, randomized, assessor-blinded, active controlled, parallel group, two arm, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml + Brimonidine tartrate 2 mg/ml eye drops suspension (AZAD Pharma AG, Switzerland) and Simbrinza® (Brinzolamide 10 mg/ml + Brimonidine tartrate 2 mg/ml) eye drops suspension (Novartis Europharm Limited, Ireland ) in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension.

Start Date25 Jul 2023

Sponsor / Collaborator

AZAD Pharma AG

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EUCTR2022-002524-12-BG / Unknown statusPhase 3

A prospective, phase III, multicenter, randomized, investigator-blinded, two-arm, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml eye drops suspension (Brinzolamide 10mg/ml Eye Drops Suspension Preservative Free) as a test product versus AZOPT® 10 mg/ml eye drops suspension as reference product in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension

Start Date13 Apr 2023

Sponsor / Collaborator

AZAD Pharma AG

NCT03093883 / CompletedPhase 1

Open-label, Randomized, Crossover-design Bioequivalence Study With Comparing a Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection of Vifor AG in Healthy Male Volunteers

The aim of this pharmacokinetic study is to assess the bioequivalence of the generic Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG, Switzerland (reference product). Both formulations contain iron as an active ingredient. Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia in adult patients.

Start Date13 Mar 2017

Sponsor / Collaborator

AZAD Pharma AG

100 Clinical Results associated with AZAD Pharma AG

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0 Patents (Medical) associated with AZAD Pharma AG

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3

Literatures (Medical) associated with AZAD Pharma AG

Arzneimittelforschung

Physicochemical and toxicological characterization of a new generic iron sucrose preparation

Article

Author: Elford, Peter ; Schropp, Patricia ; Meier, Thomas ; Leoni, Anne-Laure ; Khov-Tran, Van ; Pater, Christian

Intravenous iron preparations are key components in the management of anaemia of various etiologies. These iron-carbohydrate complexes permit safe systemic delivery of iron, whilst protecting from the potential toxic effects of over-saturation. This in turn permits efficient haematopoiesis following erythropoietin administration. Since the rate of release of iron is dependent upon the structure of this iron-carbohydrate complex, it is essential to ensure that an intravenous iron preparation is well characterized and its properties documented. This report describes physicochemical and toxicological studies into a new iron sucrose generic preparation, "Iron Sucrose Azad (ISA)", using the original iron sucrose product as reference. It could be demonstrated that the specifications and physicochemical characteristics of ISA reflect those of the reference product. Furthermore, in a rat model previously shown to identify possible toxicological effects of "unsimilar" iron sucrose preparations, ISA was found to have the same properties as the reference product, with both being well tolerated.

Sustainable and Scalable Synthesis of Noroxymorphone via a Key Electrochemical N-Demethylation Step

Author: Thurnheer, Urs ; Kappe, C. Oliver ; Sommer, Florian ; Cantillo, David ; Gerber Aeschbacher, Roman

Noroxymorphone is a pivotal intermediate in the synthesis of important opioid antagonists such as naloxone and naltrexone. The preparation of noroxymorphone from thebaine, a naturally occurring opioate isolated from poppy extract, is a multistep sequence in which oxycodone is first generated and then N- and O-demethylated. Both demethylations are problematic from the safety and sustainability viewpoint, as they involve harmful reagents such as alkyl chloroformates or boron tribromide. Herein, we present a green, safe an efficient telescoped process for the N- and O-demethylation of oxycodone. The method is based on the anodic oxidative intramolecular cyclization of the N-methyl tertiary amine with the 14-hydroxyl group of the morphinan, followed by hydrolysis with hydrobromic acid, which releases the carbon from both heteroatoms. The electrolysis process has been transferred to a scalable flow electrolysis cell, significantly improving the reaction throughput and increasing the space-time yield over 300-fold with respect to batch. The sustainability of the new methodology has been assessed by means of green metrics and qualitative indicators. The sustainability assessment has demonstrated that the new methodology is far superior to the conventional chloroformate process

Chemical Journal of Armenia

Մոդիֆիկացված մոտեցում բուպրենորֆինի արտադրական սինթեզին

Author: Զինսեր, Հ. ; Մովսիսյան, Մ․ Լ. ; Դանիելյան, Թ. Հ. ; Գրիգորյան, Մ. Ռ. ; Ներկարարյան, Ք. Հ. ; Գևորգյան, Գ. Կ. ; Բարսեղյան, Կ. Ս. ; Դարիբյան, Մ. Հ.

100 Deals associated with AZAD Pharma AG

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100 Translational Medicine associated with AZAD Pharma AG

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