| Статус: | Not yet recruiting |
| Фаза: | N/A |
| Начало: | 15 июня 2024 г. |
| Окончание: | 30 декабря 2024 г. |
| Описание: | 1. 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; 2. 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. 3. 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. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 1 |
| Начало: | 4 декабря 2023 г. |
| Окончание: | 31 декабря 2024 г. |
| Описание: | Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 15 сентября 2023 г. |
| Окончание: | 1 октября 2025 г. |
| Описание: | Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 2/Phase 3 |
| Начало: | 27 мая 2023 г. |
| Окончание: | 15 июня 2025 г. |
| Описание: | Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease. Intrahepatic cholestasis syndrome, or bile retention, occurs in 11-55% of cases of diffuse chronic liver diseases, usually leads to a worsening of the liver disease, a decrease in the effectiveness of treatment. The drug REMAXOL® is a solution for infusion, which has shown high effectiveness in the syndrome of intrahepatic cholestasis in cases of liver dysfunction due to acute or chronic damage. The study drug REMAXA® enteric-coated tablets is a hybrid drug which contains the same active metabolites as REMAXOL, i.e. inosine, methionine, nicotinamide, and succinic acid. The purpose of this study is to select the optimal dose and dosage regimen followed by evaluation safety and efficacy of REMAXA®, enteric-coated tablets, in comparison with REMAXOL®, solution for infusion, in patients who suffer from chronic diffuse liver diseases and have intrahepatic cholestasis. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1 |
| Начало: | 15 июля 2016 г. |
| Окончание: | 26 января 2017 г. |
| Описание: | Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers. |
| смотреть на ClinicalTrials.gov |