The safety and tolerability study of tiozonid in single dose with it increasing
A study of the safety and tolerability tiozonid manufacturing by JSC «Pharm-Sintez» (Russia) at the single dose with it increasing (25, 200, 400 and 600 mg) in healthy volunteers. In each group, the volunteers were enrolled sequentially, based on the interim evaluation of safety parameters. This stu...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Izdatelstvo OKI
2018-05-01
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| Series: | Качественная клиническая практика |
| Subjects: | |
| Online Access: | https://www.clinvest.ru/jour/article/view/56 |
| _version_ | 1797262139924152320 |
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| author | A. U. Savchenko G. V. Ramenskaya M. S. Bourenkov |
| author_facet | A. U. Savchenko G. V. Ramenskaya M. S. Bourenkov |
| author_sort | A. U. Savchenko |
| collection | DOAJ |
| description | A study of the safety and tolerability tiozonid manufacturing by JSC «Pharm-Sintez» (Russia) at the single dose with it increasing (25, 200, 400 and 600 mg) in healthy volunteers. In each group, the volunteers were enrolled sequentially, based on the interim evaluation of safety parameters. This study was conducted in compliance with the requirements of legislation and the ethical principles set forth in the Federal Law «On Circulation of Medicines» (number 61-FZ of April 12, 2010), the Declaration of Helsinki of the World Medical Association (1964, with subsequent amendments), GOST R 52379-2005 «Good clinical practice» The study drug tiozonid manufacturing by JSC «Pharm-Sintez» (Russia) has shown a sufficiently high safety and well-tolerated at single oral doses in the range of 25-600 mg. |
| first_indexed | 2024-04-24T23:52:22Z |
| format | Article |
| id | doaj.art-cde59ae9c885437487831b6f11d05cf6 |
| institution | Directory Open Access Journal |
| issn | 2588-0519 2618-8473 |
| language | Russian |
| last_indexed | 2024-04-24T23:52:22Z |
| publishDate | 2018-05-01 |
| publisher | Izdatelstvo OKI |
| record_format | Article |
| series | Качественная клиническая практика |
| spelling | doaj.art-cde59ae9c885437487831b6f11d05cf62024-03-14T18:09:03ZrusIzdatelstvo OKIКачественная клиническая практика2588-05192618-84732018-05-0103434856The safety and tolerability study of tiozonid in single dose with it increasingA. U. Savchenko0G. V. Ramenskaya1M. S. Bourenkov2ФГБУН НЦБМТ ФМБА РоссииФГБОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава РоссииАО «Фарм-Синтез»A study of the safety and tolerability tiozonid manufacturing by JSC «Pharm-Sintez» (Russia) at the single dose with it increasing (25, 200, 400 and 600 mg) in healthy volunteers. In each group, the volunteers were enrolled sequentially, based on the interim evaluation of safety parameters. This study was conducted in compliance with the requirements of legislation and the ethical principles set forth in the Federal Law «On Circulation of Medicines» (number 61-FZ of April 12, 2010), the Declaration of Helsinki of the World Medical Association (1964, with subsequent amendments), GOST R 52379-2005 «Good clinical practice» The study drug tiozonid manufacturing by JSC «Pharm-Sintez» (Russia) has shown a sufficiently high safety and well-tolerated at single oral doses in the range of 25-600 mg.https://www.clinvest.ru/jour/article/view/56безопасность и переносимостьтиозонидздоровые добровольцыsafety and tolerabilitytiozonidhealthy volunteers |
| spellingShingle | A. U. Savchenko G. V. Ramenskaya M. S. Bourenkov The safety and tolerability study of tiozonid in single dose with it increasing Качественная клиническая практика безопасность и переносимость тиозонид здоровые добровольцы safety and tolerability tiozonid healthy volunteers |
| title | The safety and tolerability study of tiozonid in single dose with it increasing |
| title_full | The safety and tolerability study of tiozonid in single dose with it increasing |
| title_fullStr | The safety and tolerability study of tiozonid in single dose with it increasing |
| title_full_unstemmed | The safety and tolerability study of tiozonid in single dose with it increasing |
| title_short | The safety and tolerability study of tiozonid in single dose with it increasing |
| title_sort | safety and tolerability study of tiozonid in single dose with it increasing |
| topic | безопасность и переносимость тиозонид здоровые добровольцы safety and tolerability tiozonid healthy volunteers |
| url | https://www.clinvest.ru/jour/article/view/56 |
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