Open, Comparative, Randomized, Crossover, Single Dose Bioequivalence Study of Metformin 500 mg Prolonged Release Tablets (JSC Farmak, Ukraine) vs Glucophage® XR 500 mg Prolonged Release Tablets in Healthy Subjects Under Fasting Conditions.

This study was designed to compare the bioavailability of the Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fasting conditions.

开始日期2021-05-21

申办/合作机构

Farmak

NCT05123976

/ Completed临床1期

A Comparative, Open-label, Randomized, Two-period Bioequivalence Study of Olanzapine Film-coated Tablets 5 mg (JSC Farmak, Ukraine) vs Zyprexa® Coated Tablets 5 mg (Eli Lilly, Nederland B V) in Healthy Subjects Under Fasted Conditions.

This study was designed to assess the bioequivalence of Olanzapine tablets of two different manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two different manufacturers.

开始日期2020-10-21

申办/合作机构

Farmak

NCT04682873

/ Completed临床3期

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Trial to Assess the Efficacy and Safety of Amizon® Max, Manufactured by Farmak JSC, in Combination With Basic Treatment, in Subjects With Moderate Covid-19, Which is Caused by the SARS-CoV-2 Virus

Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial.
Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29.
The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (Es).
Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.

开始日期2020-05-15

申办/合作机构

Farmak

100 项与 Farmak 相关的临床结果

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0 项与 Farmak 相关的专利（医药）

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项与 Farmak 相关的文献（医药）

2021-05-28·Acta Poloniae Pharmaceutica - Drug Research

Development of the technology of a liposomal form of eye drops based on a peptide complex

作者: Yarnykh, Tatyana ; Rukhmakova, Olga ; Kruglov, Eugene ; Borshchevsky, Gennady

The aim of this work is to develop the stage of inclusion of the active pharmaceutical ingredient in liposomes, to study the effect of liposome composition on the degree of encapsulation and particle size in creating a liposomal eye drops based on a peptide complex used as a drug for ophthalmic diseases.Different concentrations of lipid membrane 80 mg/mL, 90 mg/mL, 100 mg/mL were studied.The influence of particle size on the degree of encapsulation of the peptide complex from 300 nm to 80 nm was studied.The highest degree of encapsulation of the peptide complex was determined for a liposomal sample with a lipid concentration of 100 mg/mL and a particle size of 120-140 nm or less.

2019-01-01·Methods and Objects of Chemical Analysis

Monitoring And Distribution Of Organochlorine Pesticides, Polychlorinated Biphenyls And Polycyclic Aromatic Hydrocarbons In Surface River Water And Suspended Particulate Matter

作者: MILYUKIN, M.V. ; Skrynnyk, M.M. ; Gorban, M.V.

The monitoring results of organochlorine pesticides (OCPs), polychlorinated biphenyls (PCBs) and polycyclic aromatic hydrocarbons (PAHs) in Ukranian and world surface river waters were summarized. Total concentrations of OCPs, PCBs and PAHs in surface waters of Ukrainian rivers (Dnieper and Dniester) were 1.4–17.1; 2.8–57.2; 7.5–378.6 ng/dm3 , respectively. These pollution levels are medium on a global scale. Higher concentrations were recorded in the surface water of China, India and other Asian countries. Distribution of these organic ecotoxicants between water and suspended particulate matter (dispersionphase distribution) was analyzed and it was shown that in the majority of river waters ≥50% of them are associated with suspended particles. By the case of River Dnieper antibate correlations between watersoluble parts of individual OCPs, PCBs and PAHs and coefficient of their hydrophobicity were recorded. These correlations were presented graphically. In addition, relevant correlation coefficients and criterions of probability were calculated. The clearest correlation was established for PCBs.

Current issues in pharmacy and medicine: science and practice

Development of the technology of tablets on the basis of ademetionine 1,4-butanedisulfonate

作者: K. S. Burdak ; T. G. Yarnyh ; M. I. Borshchevska

During medicinal product development a lot of key points should be taken into consideration. The purpose of pharmaceutical development is not only the creation of effective and safe preparation but also the organization of appropriate conditions for the process of production that could provide its recovery rate. The choice of optimized composition for medicinal product and the development of technology help to define the interval of allowed parameters’ values of the process and subcomponents of the recipe, following of which guarantees correspondence of the final product to the specification limit [7]. Objective. To develop technology for the production of film-coated tablets based on 1,4-ademetionine butanedisulfonate, which corresponds to the given specification. Materials and methods. Wet and dry granulation structure was used in the development of methods. Bulk density, flow ability and the angle of deflection were determined in the prepared mixtures. Formulation was analyzed in all parameters according to the specifications, including the examination of options such as decay, dissolution, abrasion and crush resistance. Results. The technology and definitive conditions for preparation on the basis of the ademetionine 1,4-butanedisulfonate substance were created and selected. Next criteria of optimization have been defined: flow ability, bulk density for performing and also crush resistance, friability and disintegration of ready pills. Critical value is humidity of the substance that influences the quality of the production and requires appropriate production conditions. Conclusions. On the basis of studying of the influence of relative degree of humidity and pressing efforts on the factors that were mentioned above it was established that the most rational method of getting the pills is performing with previous granulation of a mass. By means of physical-chemical (flow ability, bulk density, angle of deviation) and technological (resistance to crushing, abrasion, dissolution and disintegration) research methods, it was proved that this technology allows to obtain tablets that are fully compliant with specifications for the tablets covered with an enteric coating.

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