دورية أكاديمية
Pharmacokinetic parameters, safety and drug-drug interactions of mirtazapine and tizanidine, combined in the new original drug Dorsumio® ; Изучение фармакокинетических параметров, безопасности и межлекарственного взаимодействия миртазапина и тизанидина в составе нового оригинального лекарственного препарата Дорсумио®
| العنوان: | Pharmacokinetic parameters, safety and drug-drug interactions of mirtazapine and tizanidine, combined in the new original drug Dorsumio® ; Изучение фармакокинетических параметров, безопасности и межлекарственного взаимодействия миртазапина и тизанидина в составе нового оригинального лекарственного препарата Дорсумио® |
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| المؤلفون: | A. S. Goncharov, A. V. Grigoriev, A. A. Globenko, I. S. Goncharov, K. A. Muratov, D. V. Yaroshenko, A. A. Sidorova, A. V. Kapashin, O. V. Kovchan, A. I. Bashkatova, M. A. Pasko, А. С. Гончаров, А. В. Григорьев, А. А. Глобенко, И. С. Гончаров, К. А. Муратов, Д. В. Ярошенко, А. А. Сидорова, А. В. Капашин, О. В. Ковчан, А. И. Башкатова, М. А. Пасько |
| المساهمون: | This article has been supported by Valenta Pharm., Статья спонсируется компанией «Валента Фарм». |
| المصدر: | Neurology, Neuropsychiatry, Psychosomatics; Vol 15, No 4 (2023); 80-88 ; Неврология, нейропсихиатрия, психосоматика; Vol 15, No 4 (2023); 80-88 ; 2310-1342 ; 2074-2711 ; 10.14412/2074-2711-2023-4 |
| بيانات النشر: | "IMA-Press", LLC |
| سنة النشر: | 2023 |
| المجموعة: | Neurology, Neuropsychiatry, Psychosomatics (E-Journal) / Неврология, нейропсихиатрия, психосоматика |
| مصطلحات موضوعية: | безопасность, mirtazapine, tizanidine, Dorsumio®, safety, миртазапин, тизанидин, Дорсумио® |
| الوصف: | Objective: to study the pharmacokinetic parameters and safety of Dorsumio® (mirtazapine + tizanidine, extended-release tablets, 15 mg + 6 mg, JSC Valenta Pharm, Russia) taken once by healthy volunteers in comparison with Calixta®, a monocomponent drug (INN: Mirtazapine, filmcoated tablets, 30 mg, Belupo, Drugs and Cosmetics d.d., Republic of Croatia) and Sirdalud® MR (INN: Tizanidine, modified-release capsules, 6 mg, Novartis Pharma AG, Switzerland) with an evaluation of their drug interactions when taken concomitantly or separately.Material and methods. A two-stage, randomized, comparative cross-over study of the pharmacokinetics and safety of the complex drug Dorsumio® was conducted. In the first stage, volunteers alternated between taking one or two tablets of the study drug in two administration periods; in the second stage, subjects alternated between taking the reference monodrugs Calixta® and Sirdalud® MR alone and in a joint combination in three administration periods. A total of 38 volunteers were randomized into the study, of which 14 subjects participated in the first and 24 in the second stage of the study. Quantitative levels of mirtazapine and tizanidine were determined by high-performance liquid chromatography with tandem mass spectrometry. Based on the data obtained, the main pharmacokinetic parameters reflecting the bioavailability of each drug were calculated, and the mutual influence of their combination on pharmacokinetics was also studied. During the study, vital signs and laboratory parameters of the subjects were monitored, and the occurrence of adverse events (AEs) and serious AEs was recorded.Results. A two-fold increase in the dose of the combination drug Dorsumio® resulted in a comparable increase in the pharmacokinetics of the individual drugs. There was no significant reciprocal effect of mirtazapine and tizanidine on their pharmacokinetic parameters. In one of the subjects participating in the second stage of the study, two mild side effects were registered after the joint use of ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | Russian |
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| DOI: | 10.14412/2074-2711-2023-4-80-88 |
| الإتاحة: | https://doi.org/10.14412/2074-2711-2023-4-80-88Test https://doi.org/10.14412/2074-2711-2023-4Test https://doi.org/10.21518/2079-701X-2022-16-23-60-66Test https://doi.org/10.1007/s00586-006-1072-1Test https://doi.org/10.33978/2307-3586-2019-15-19-38-42Test https://doi.org/10.1097/PR9.0000000000000919Test https://doi.org/10.1002/ddr.21229Test https://doi.org/10.1097/00000539-200111000-00057Test https://doi.org/10.1213/01.ANE.0000048087.57487.0CTest https://doi.org/10.1155/2015/902914Test |
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| رقم الانضمام: | edsbas.14883D20 |
| قاعدة البيانات: | BASE |
| DOI: | 10.14412/2074-2711-2023-4-80-88 |
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