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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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22

项与 Farmak 相关的文献（医药）

2021-05-28·ACTA POLONIAE PHARMACEUTICA

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

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

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

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.

Ukrainian Biopharmaceutical Journal

Research of the excipients quantitative characteristics influence on the basic quality indicators of amlodipine with enalapril tablets

作者: Behei, N. ; Tryhubchak, O.

Topicality.Arterial hypertension remains one of the most common diseases in Ukraine.Pharmaceutical development provides creating effective, high-quality and safe medicines.Aim.To study the influence of quant. factors on pharmacotechnol. parameters of amlodipine with enalapril tablets.Materials and methods.We selected excipients grouped in 7 factors and studied them at the lower and upper levels.A random balance method used for the plan of the experimentThe obtained tablets have been analyzed according to the requirements of the State Pharmacopoeia of Ukraine.Significant factors have been determined by the scatter plots.Results and discussion.The excipients quantity influence on the pharmacotechnol. characteristics of the granulate (loss on drying), tablet mass (flowability, angle of repose, bulk d., tapped d.) and amlodipine with enalapril tablets (uniformity of mass, hardness, friability and disintegration) studied.Conclusions.It has been selected the number of excipients providing the pharmacotechnol. properties of the granulate, tablet mass and amlodipine with enalapril tablets according to current pharmacopoeia requirements.

100 项与 Farmak 相关的药物交易

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100 项与 Farmak 相关的转化医学

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