NEW ANTIVIRAL DRUG TRIAZAVIRIN. RESULTS OF PHASE 1 CLINICAL TRIAL
E. G Deeva , leg Ivanovich Kiselev , Tatjana Ilinichna Melnikova , Aram Arutjunovich Shaldzhan , Petr Alexeevich Nekrasov , Alexey Sergeevich Kiselev , Ksenia Alexandrovna Zagorodnikova , Valeriy Nikolaevich Charushin , Vladimir Leonidovich Rusinov , Evgeniy Narcissovich Ulomsky , Oleg Nikolaevich Chupakhin
Epidemiology and Infectious Diseases ›› 2013, Vol. 18 ›› Issue (5) : 20 -26.
NEW ANTIVIRAL DRUG TRIAZAVIRIN. RESULTS OF PHASE 1 CLINICAL TRIAL
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.
triazavirin / influenza / clinical trial / safety / pharmacokinetics
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