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NEW ANTIVIRAL DRUG TRIAZID. RESULTS OF FIRST PHASE OF CLINICAL TRIAL

Abstract

The paper contains а results of the study of the pharmacokinetics, tolerability and safety of a new influenza drug Triazide in several dose regimens conducted on healthy volunteers. The convenient method for the determining the Triazide in blood plasma and urine by the HPLC have been proposed for the using in this study. There was no reliable statistical relationship between drug intake, undesirable clinical events and changes in laboratory parameters. A study of the pharmacokinetics have been showed that Triazide in the blood plasma was found on average after 0.5 hours, the curve of decrease in concentrations was two-phase, the half-life in the first phase was 1.5-4.0 hours. The maximum concentrations with increasing dose increased in direct proportion. With an increase in the daily dose, the maximum concentration was reached earlier. At the same time, no significant cumulation was observed with prolonged use. In the study, Triazide was well tolerated by all participants in all studied dose regimens. Preferred regimens that provide maintenance of effective and safe concentrations, appearances were 300 mg two and three times a day.

About the Authors

E. G. Deyeva
Research Institute of Influenza of Ministry of healthcare of the Russian Federation
Russian Federation


Yu. I. Shevchik
Research Institute of Influenza of Ministry of healthcare of the Russian Federation
Russian Federation


A. A. Shaldghan
Research Institute of Influenza of Ministry of healthcare of the Russian Federation
Russian Federation


K. A. Zagorodnikova
North-Western State Medical University named after I. I. Mechnikov
Russian Federation


A. A. Tumashov
I. Ya. Postovsky Institute of organic synthesis of UB of RAS
Russian Federation


A. V. Baklykov
I. Ya. Postovsky Institute of organic synthesis of UB of RAS; Ural Federal University named after the first President of Russia B. N. Yeltsin
Russian Federation


S. K. Kotovskaya
I. Ya. Postovsky Institute of organic synthesis of UB of RAS; Ural Federal University named after the first President of Russia B. N. Yeltsin
Russian Federation


O. N. Chupahin
I. Ya. Postovsky Institute of organic synthesis of UB of RAS; Ural Federal University named after the first President of Russia B. N. Yeltsin
Russian Federation


V. N. Charushin
I. Ya. Postovsky Institute of organic synthesis of UB of RAS; Ural Federal University named after the first President of Russia B. N. Yeltsin
Russian Federation


V. L. Rusinov
I. Ya. Postovsky Institute of organic synthesis of UB of RAS; Ural Federal University named after the first President of Russia B. N. Yeltsin
Russian Federation


D. S. Kopchuk
I. Ya. Postovsky Institute of organic synthesis of UB of RAS; Ural Federal University named after the first President of Russia B. N. Yeltsin
Russian Federation


References

1. Kiselev O. I. Avian influenza and pandemic of “swine” influenza H1N1 of 2009 year. - SPb.: Foliant, 2016. 368 p.

2. Avian influenza: the origin of infectious catastrophes: Sat. articles / Ed. Pokrovsky V.I. et al. - SPb.: Rostok, 2012. 304 p.

3. Ligon B. L. Avian influenza virus H5N1: a review of its history and information regarding its potential to cause the next pandemic // Semin. Pediatr. Infect. Dis. 2005. V. 16. P. 326.

4. Reddy D. Responding to pandemic (H1N1) 2009 influenza: the role of oseltamivir // J. Antimicrob. Chemother. 2010. V. 65. P. ii35.

5. Update: Drug Susceptibility of Swine-Origin Influenza A (H1N1) Viruses // JAMA. 2009. V. 301. P. 2086.

6. Kiselev O. I. Chemodrugs and chemotherapy for influenza. - SPb.: Rostok, 2012. 272 p.

7. Deeva E. G. Influenza. On the eve of a pandemic. - M.: GEOTAR-Media, 2008. 208 p.

8. Patent RU 2529487. 5-Methyl-6-nitro-7-oxo-1,2,4-triazolo[1,5-a]pyrimidinide l-arginine monohydrate / Chupakhin О. N., Charushin V. N., Rusinov V. L., Ulomsky Е. N., Коtovskaya S. К., Kiselev О. I., Deeva E. G., Savateev К. V., Borisov S. S.; patentoobladatel’ IOS UrB RAS. - Zajavl. 15.04.13; opubl. 27.09.14.

9. Gosselin R.E., Hodge H., Smith R.P., Gleason M.N. Clinical Toxicology of Commercial Products: Acute Poisoning. Ed. IV. - Baltimor: Williams & Wilkins, 1976. 332 p.

10. National standard of the Russian Federation «Good Clinical Practice» from 04.01.2006.

11. Order of the Ministry of Health of Russia No. 266 of June 19, 2003 “On the approval of the rules of clinical practice in the Russian Federation”.

12. Guideline for good clinical practice, 1996. ICH harmonised tripartite guideline. International Conference on Harmonisation. URL: http://www.ich.org/LOB/media/MEDIA482.pdf (accessed on 08.08.2018).

13. Federal Law № 61-FZ of 12.04.2010 «On circulation of drugs».

14. Khabriev R. U. Guidelines for the clinical trials of new drugs. - M.: Scientific Centre for Expert Evaluation of Medicinal Products, 2005. 357 p.

15. Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. 2005. FDA/CDER. URL: http://www.fda.gov/cder/guidance/index.htm (accessed on 08.08.2018).


Review

For citations:


Deyeva E.G., Shevchik Yu.I., Shaldghan A.A., Zagorodnikova K.A., Tumashov A.A., Baklykov A.V., Kotovskaya S.K., Chupahin O.N., Charushin V.N., Rusinov V.L., Kopchuk D.S. NEW ANTIVIRAL DRUG TRIAZID. RESULTS OF FIRST PHASE OF CLINICAL TRIAL. Drug development & registration. 2018;(3):172-180. (In Russ.)

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)