An Open-label, Randomized, Response-adaptive Crossover Study to Investigate the Comparative Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers

Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers, based on AE/SAE (adverse events/serious adverse event) analysis;
Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.
To conclude on the bioequivalence of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.

Start Date15 Jun 2024

Sponsor / Collaborator

Valenta Pharmaceuticals JSC

NCT06342804 / RecruitingPhase 1

An Open-label Crossover Study With 2 Treatments (Fasting and Fed Conditions), 2 Periods, 2 Sequences to Evaluate the Effect of Food Intake on the Bioavailability of 4-MUST, Tablets, 128 mg at a Single Dose of 256 mg in Healthy Volunteers

Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).

Start Date19 Mar 2024

Sponsor / Collaborator

Valenta Pharmaceuticals JSC

NCT06321341 / RecruitingPhase 4

Open Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of Vespireit, Prolonged-release Tablets (Valenta Pharm JSC, Russia) and Arlevert, Tablets (Menarini International Operations Luxembourg S.A., Luxembourg) in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo

Study of efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo.

Start Date24 Jan 2024

Sponsor / Collaborator

Valenta Pharmaceuticals JSC

100 Clinical Results associated with Valenta Pharmaceuticals JSC

0 Patents (Medical) associated with Valenta Pharmaceuticals JSC

Literatures (Medical) associated with Valenta Pharmaceuticals JSC

Safety and Risk of Pharmacotherapy

Preclinical Evaluation of Esomeprazole Safety and Toxicokinetics

Author: Kosman, V. M. ; Karlina, M. V. ; Makarov, V. G. ; Mazukina, E. V. ; Jain, E. A. ; Globenko, A. A. ; Makarova, M. N.

Esomeprazole, the S-isomer of omeprazole, is a second-generation proton pump inhibitor widely used for acid-related diseases of the oesophagus, stomach, and duodenum (peptic ulcer, gastro-oesophageal reflux disease, etc.). Studies on esomeprazole safety and toxicokinetics (TK) are essential for increasing the number of modified-release esomeprazole products manufactured in Russia.The aim of the studywas to compare the safety and toxicokinetics of a new esomeprazole product, 40 mg modifiedrelease capsules (Valenta Pharm JSC, Russia), and Nexium®40 mg film-coated tablets (AstraZeneca AB, Sweden).Materials and methods.This toxicity study involved oral administration of esomeprazole 40 mg modified-release capsules (Valenta Pharm JSC, Russia) and Nexium®40 mg film-coated tablets (AstraZeneca AB, Sweden) to 5 groups of rabbits (8 males and 8 females per group) for 28 days at a dose of 1 or 3 capsules, or tablets, corresponding to approximately 4.8 or 14.3 maximum human therapeutic doses (MHTDs), respectively. Comparisons included general toxicity, local tolerance, safety pharmacology, effects on immune system organs, reproductive toxicity, and basic TK parameters (Cmax,Tmax,AUC0-24,MRT, andT1/2).Results.No toxic effects, including local irritation and immunotoxicity, were observed for the test product. The safety pharmacology testing demonstrated the safety of repeated oral administration of the test product for the cardiovascular, excretory, respiratory systems and the liver. The test product did not affect the reproductive system of male and female rabbits. The No Observed Adverse Effect Level (NOAEL) was determined to be 14.3 MHTDs. According to the TK parameters evaluated after single and repeated oral administration, the test product and Nexium®demonstrated comparable TK profiles.Conclusions.The study demonstrated a favourable safety profile for the test product. All the test product parameters studied were comparable with those of Nexium®. Positive clinical experience with Nexium®supports the data obtained for the new esomeprazole product. Thea safety of these medicinal products may be considered similar.

Pharmacokinetics and Pharmacodynamics

Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study

Author: Kapashin, A. V. ; Kolmykova, E. A. ; Shmelev, A. G. ; Kovchan, O. V. ; Sidorova, A. A. ; Yastrebova, A. V. ; Globenko, A. A. ; Pasko, M. A. ; Grigorev, A. V. ; Baskakov, E. V. ; Bashkatova, A. I.

Aim. The primary aim of this study was to evaluate the pharmacokinetic parameters and conﬁrm the bioequivalence of drugs containing gidazepam, namely Gidazepam® (Valenta Pharm, Russia) and Gidazepam VIC (VIVA Pharm, Republic of Kazakhstan), after a single administration of 1 tablet (50 mg) to healthy volunteers under fasting conditions. The secondary aim was a comparative analysis of safety proﬁles (adverse events) after a single administration of the studied drugs.Materials and methods. An open, randomized, crossover, two-period comparative study of pharmacokinetics and bioequivalence with adaptive design was conducted in healthy volunteers. Blood sampling was performed 15 minutes before and 20 min, 40 min, 1 h, 2 h, 3 h, 3.5 h, 4 h, 4.5 h, 5 h, 6 h, 8 h, 12 h, 24 h, 48 h, and 72 h after drug administration. High-performance liquid chromatography-tandem mass spectrometry was used for the evaluation of gidazepam and its metabolite (desalkylgidazepam) concentration with the subsequent calculation of pharmacokinetic parameters.Results. From both formulations, gidazepam was quickly absorbed and biotransformed into an active metabolite. Studied drugs had similar pharmacokinetic proﬁles, as 90% conﬁdence intervals for the ratio of geometric means for Cmax and AUC(0-72) were within the bioequivalence acceptance range of 80.00–125.00 %. No adverse events were recorded as a result of clinical, laboratory or instrument evaluations during the study.Conclusion. Study drugs are considered bioequivalent and show comparable tolerability after a single administration under fasting conditions.

Pharmacokinetics and Pharmacodynamics

Study of antacid effect of the drug Antareit® in healthy volunteers

Author: Losevich, A. V. ; Pasko, M. A. ; Goncharov, A. S. ; Verbitskaya, E. V. ; Kapashin, A. V. ; Goncharov, I. S. ; Grigorev, A. V. ; Globenko, A. A. ; Zakharov, K. A. ; Vasilyuk, V. B.

The aim. Study of pharmacodynamic parameters and confirmation of pharmacodynamic equivalence (bioequivalence) of the drugs Antareit® (INN: magaldrate), chewable tablets, 800 mg (Valenta Pharm JSC, Russia) and Riopan (INN magaldrate), chewable tablets, 800 mg (Takeda GmbH, Germany). Material and methods. An open randomized crossover study was conducted to investigate the pharmacodynamics of the study drug Antareit® and the reference drug Riopan, assessing their bioequivalence after taking 2 chewable tablets of the study or reference drug 3 times a day. The study involved 40 healthy volunteers who were randomized into 2 groups of 20 people depending on the sequence of drug administration in study periods I and II. Intragastric acidity was measured with a pH-probe within 30 minutes before and for one hour after taking the study drugs. Based on the data obtained, 90% confidence intervals (CI) were calculated for the pharmacodynamic parameter AUCABL, reflecting the area above the baseline pH. The safety of the study drugs was assessed by the frequency and severity of adverse events (AEs). Results. Statistical analysis showed that the 90% CI for the ratio of the mean values of the AUC ABL parameter of the study drug to the reference drug did not fall below 80% (90% CI: 80.55–119.49). During the study, 18 adverse events (AEs) were reported in 15.4% (6 of 39) of volunteers in the safety population, and there were no statistically significant differences in the incidence of AEs between groups, nor in the incidence of AEs depending on the drug taken. Conclusion. The studied drugs are pharmacodynamically equivalent and have a similar safety profile when administered repeatedly.

News (Medical) associated with Valenta Pharmaceuticals JSC

20 Jul 2023

·www.prnewswire.com

Global Post-Traumatic Stress Disorder Therapeutics Market to Reach $3.42 Billion in 2023, Fueled by Strategic Collaborations and Technological Advancements

DUBLIN, July 20, 2023 /PRNewswire/ -- The "Post-Traumatic Stress Disorder Therapeutics Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering. This comprehensive report provides critical information for strategists, marketers, and senior management to assess the post-traumatic stress disorder (PTSD) therapeutics market. The market is projected to grow from $3.15 billion in 2022 to $3.42 billion in 2023, with a compound annual growth rate (CAGR) of 8.72%. Furthermore, the market is expected to reach $4.82 billion by 2027, exhibiting a CAGR of 8.96%. Major players in the post-traumatic stress disorder therapeutics market include Novartis AG, Pfizer Inc., Bionomics Ltd., Apotex Inc., GlaxoSmithKline PLC., Otsuka Pharmaceutical Co. Ltd., Eli Lilly and Company, Aurobindo Pharma Limited, Merck KGaA, Sun Pharmaceuticals Pvt Ltd., Strategic Behavioral Health, Jazz Pharmaceuticals, Bionomics, Behavioral Health Network Inc., AstraZeneca PLC., Apotex Inc., Prometheon Pharma LLC., Ligand Pharmaceuticals Incorporated, Lycera Corp., and JSC Valenta Pharm. Reasons to Purchase: Gain a comprehensive global perspective with detailed coverage of 50+ geographies. Understand the market's response to COVID-19 and its impact as the virus abates. Assess the direct and indirect effects of the Russia-Ukraine war on agriculture, energy, mineral commodity supply, and the market. Measure the influence of high global inflation on market growth. Develop regional and country-specific strategies based on localized data and analysis. Identify investment opportunities in growth segments. Outperform competitors using forecast data and insights into market drivers and trends. Understand customer dynamics based on the latest market shares. Benchmark performance against key competitors. Support internal and external presentations with reliable high-quality data and analysis. Post-traumatic stress disorder therapeutics encompass treatments used to address PTSD, a mental health condition triggered by experiencing or witnessing traumatic events. These therapies aim to improve patients' cognitive abilities, physical activity, and regain a sense of control over their lives. Treatment modalities for PTSD include medication, therapy, self-care, and nutrition. The main drug categories in PTSD therapeutics include antidepressants, anti-anxiety medications, antihypertensive drugs, monoamine oxidase inhibitors (MAOIs), antipsychotics or second-generation antipsychotics (SGAs), beta-blockers, and others (such as benzodiazepines). Antidepressants are used to manage addiction and treat conditions like major depressive disorder, anxiety disorders, and chronic pain. Therapeutic services cater to different age groups, including pediatric, geriatric, and adults, and are provided by mental health centers, hospitals, outpatient clinics, and other facilities. Strategic collaborations, funding, and investments are emerging trends in the PTSD therapeutics market, with major companies forging partnerships and investing in other organizations to strengthen their market position. For example, in January 2022, Professor Dan Lubman AM, Dr. Shalini Arunogiri, and Dr. Paul Liknaitzky of Monash University received over $1.9 million to study the effectiveness of MDMA-assisted psychological treatment for alcohol use disorder (AUD) and PTSD. This research initiative is part of seven clinical studies under the Medical Research Future Fund (MRFF), supported by the Australian Federal Government, to explore the use of potentially groundbreaking combination therapies for debilitating mental illnesses. North America dominated the post-traumatic stress disorder therapeutics market in 2022, while Asia-Pacific is expected to witness the highest growth during the forecast period. The regions covered in the report include Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. Key countries analyzed in the report include Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA. The increasing burden of PTSD cases worldwide is expected to drive the growth of the post-traumatic stress disorder therapeutics market. PTSD is a disorder that develops in individuals who have experienced or witnessed scary, shocking, or dangerous events. Therapeutic interventions, including psychotherapy and medication, play a crucial role in helping individuals regain a sense of control over their lives. According to the United States Department of Veterans Affairs, nearly 8 million Americans were estimated to be suffering from PTSD in 2021. The rising burden of PTSD cases underscores the need for effective therapeutics and fuels the growth of the post-traumatic stress disorder therapeutics market. The post-traumatic stress disorder therapeutics market includes revenues earned by entities providing treatment services such as psychotherapy, medication, and combination therapies. The market value comprises the value of related goods and services sold by the service providers. The market also includes sales of specific drugs used in PTSD treatment, such as Sertraline, Paroxetine, and Fluoxetine. Key Topics Covered: 1. Executive Summary 2. Post-Traumatic Stress Disorder Therapeutics Market Characteristics 3. Post-Traumatic Stress Disorder Therapeutics Market Trends And Strategies 4. Post-Traumatic Stress Disorder Therapeutics Market - Macro Economic Scenario 4.1. COVID-19 Impact On Post-Traumatic Stress Disorder Therapeutics Market 4.2. Ukraine-Russia War Impact On Post-Traumatic Stress Disorder Therapeutics Market 4.3. Impact Of High Inflation On Post-Traumatic Stress Disorder Therapeutics Market 5. Post-Traumatic Stress Disorder Therapeutics Market Size And Growth 5.1. Global Post-Traumatic Stress Disorder Therapeutics Historic Market, 2017-2022, $ Billion 5.1.1. Drivers Of The Market 5.1.2. Restraints On The Market 5.2. Global Post-Traumatic Stress Disorder Therapeutics Forecast Market, 2022-2027F, 2032F, $ Billion 5.2.1. Drivers Of The Market 5.2.2. Restraints On the Market 6. Post-Traumatic Stress Disorder Therapeutics Market Segmentation 6.1. Global Post-Traumatic Stress Disorder Therapeutics Market, Segmentation By Drug Class, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Antidepressants Anti-Anxiety Antihypertensive Monoamine Oxidase (MAOs) Antipsychotics Or Second Generation Antipsychotics (SGOs) Beta-Blockers Other Classes 6.2. Global Post-Traumatic Stress Disorder Therapeutics Market, Segmentation By Age Group, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Pediartic Geriatric Adult 6.3. Global Post-Traumatic Stress Disorder Therapeutics Market, Segmentation By End User, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Mental Health Center Hospitals Outpaitent Clinics Other End Users 7. Post-Traumatic Stress Disorder Therapeutics Market Regional And Country Analysis 7.1. Global Post-Traumatic Stress Disorder Therapeutics Market, Split By Region, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion 7.2. Global Post-Traumatic Stress Disorder Therapeutics Market, Split By Country, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with Valenta Pharmaceuticals JSC

100 Translational Medicine associated with Valenta Pharmaceuticals JSC

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 1 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ingavirin	Neutropenia More	Approved
Dioxidin	Pyoderma More	Phase 3
Ranquilon ( CCK receptor )	Adjustment disorders More	Phase 3
4-Methylumbelliferyl Trimebutine Sulfate	Cholecystitis More	Phase 1
Magaldrate	Heartburn More	Pending

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis