NEW ANTIVIRAL DRUG TRIAZAVIRIN. RESULTS OF PHASE 1 CLINICAL TRIAL


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Abstract

In the work there are presented results of the study of the pharmacokinetics, tolerability and safety of a new anti-influenza preparation Triazavirin in several dose regimes, performed in 30 volunteers. There were no recorded adverse reactions associated with the administration of the drug. Study of the pharmacokinetics showed that the maximum concentration of Triazavirin in blood plasma is achieved on average 1 - 1.5 hours after, the curve of decreasing concentrations is two-phase, half-life elimination period in the first phase is 0.5 - 1.4 hour. It is impossible to exclude polymorphic character of metabolism. The extent of systemic exposure depends on the dosage frequency more than the dose of the drug. In this case, there was no noted significant accumulation in long-term use. In the study Triazavirin was well tolerated by all participants in all the studied dose regimes. The preferred regime, providing the maintenance of an effective and safe concentrations is recognized as dosage of the 250 mg twice a day.

About the authors

E. G Deeva

Research Institute of Influenza

Email: edeeva@hotmail.com
канд. мед. наук, вед. науч. сотр. 15/17, prof. Popov Str., Saint-Petersburg, Russian Federation, 197376

leg Ivanovich Kiselev

Research Institute of Influenza

Email: office@influenza.spb.ru
доктор биол. наук, проф., директор 15/17, prof. Popov Str., Saint-Petersburg, Russian Federation, 197376

Tatjana Ilinichna Melnikova

Research Institute of Influenza

Email: melnicov12@mail.ru
канд. биол. наук, ст. науч. сотр. 15/17, prof. Popov Str., Saint-Petersburg, Russian Federation, 197376

Aram Arutjunovich Shaldzhan

Research Institute of Influenza

лаборант-исследователь 15/17, prof. Popov Str., Saint-Petersburg, Russian Federation, 197376

Petr Alexeevich Nekrasov

Research Institute of Influenza

науч. сотр. 15/17, prof. Popov Str., Saint-Petersburg, Russian Federation, 197376

Alexey Sergeevich Kiselev

The St.Petersburg V.M. Bekhterev Psychoneurological Research Institute

специалист по биомедицинской статистике 3, Bekhterev Str., Saint-Petersburg, Russian Federation, 192019

Ksenia Alexandrovna Zagorodnikova

North-Western State Medical University named after I.I. Mechnikov

канд. мед. наук, доцент курса клинической фармакологии каф. госпитальной терапии 41, Kirochnaya street, Saint Petersburg, Russian Federation, 191015

Valeriy Nikolaevich Charushin

Institute of organic synthesis of the Urals Branch of Russian Academy of Sciences named after I. Ya. Postovsky

доктор хим. наук, акад., директор 22/20 , S. Kovalevskoy/Akademicheskaya Str., Ekaterinburg, Russian Federation, GSP-J47, 620990

Vladimir Leonidovich Rusinov

Ural Federal University named after the first President of Russia B.N. Yeltsin

доктор хим. наук, проф. каф. органической химии J9, Mira Str., Ekaterinburg, Russian Federation, 620002

Evgeniy Narcissovich Ulomsky

Ural Federal University named after the first President of Russia B.N. Yeltsin

доктор хим. наук, проф. каф. органической химии J9, Mira Str., Ekaterinburg, Russian Federation, 620002

Oleg Nikolaevich Chupakhin

Institute of organic synthesis of the Urals Branch of Russian Academy of Sciences named after I. Ya. Postovsky

доктор хим. наук, акад., науч. рук. 22/20 , S. Kovalevskoy/Akademicheskaya Str., Ekaterinburg, Russian Federation, GSP-J47, 620990

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