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Aim. The primary aim of this study was to evaluate the pharmacokinetic parameters and confirm the bioequivalence of drugs containing gidazepam, namely Gidazepam® (Valenta Pharm, Russia) and Gidazepam VIC (VIVA Pharm, Republic of Kazakhstan), after a single administration of 1 tablet (50 mg) to healthy volunteers under fasting conditions. The secondary aim was a comparative analysis of safety profiles (adverse events) after a single administration of the studied drugs.Materials and methods. An open, randomized, crossover, two-period comparative study of pharmacokinetics and bioequivalence with adaptive design was conducted in healthy volunteers. Blood sampling was performed 15 minutes before and 20 min, 40 min, 1 h, 2 h, 3 h, 3.5 h, 4 h, 4.5 h, 5 h, 6 h, 8 h, 12 h, 24 h, 48 h, and 72 h after drug administration. High-performance liquid chromatography-tandem mass spectrometry was used for the evaluation of gidazepam and its metabolite (desalkylgidazepam) concentration with the subsequent calculation of pharmacokinetic parameters.Results. From both formulations, gidazepam was quickly absorbed and biotransformed into an active metabolite. Studied drugs had similar pharmacokinetic profiles, as 90% confidence intervals for the ratio of geometric means for Cmax and AUC(0-72) were within the bioequivalence acceptance range of 80.00–125.00 %. No adverse events were recorded as a result of clinical, laboratory or instrument evaluations during the study.Conclusion. Study drugs are considered bioequivalent and show comparable tolerability after a single administration under fasting conditions.

Abstract The article presents results of a multicenter, randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of inosine glycylcysteinyl-glutamate disodium (Molixan®) in the treatment of acute severe ethanol poisoning.The aim of the study To evaluate the efficacy and safety of inosine glycyl-cysteinyl-glutamate disodium in a new dosage regimen in the treatment of severe ethanol poisoning.Material and Methods The material of the study is the data of 133 patients with severe ethanol poisoning. Inclusion criteria: age from 18 to 60 years, 1–2 coma stage (Glasgow-Pittsburgh coma scale of 14–27), ethanol in the blood of more than 2.5%. The patients were randomized into 2 groups: the Study Drug group (SD group) — 67 patients who, in addition to the standard therapy, were injected with the study drug - inosine glycyl-cysteinyl-glutamate disodium in a dose of 3.0 mg/kg; and the Placebo group — 66 patients who, in addition to the standard therapy, were injected with 0.9% sodium chloride solution in a dose of 3.0 mg/kg. Comparative intergroup and intragroup analyses were carried out according to the main clinical, laboratory parameters and EEG monitoring data.Results The study showed a positive effect of the study drug — a reduction in the coma period was noted (from 137 (75; 180) minutes to 78 (50; 155) minutes (p