Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study
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 health...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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LLC “Publisher OKI”
2023-11-01
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| Series: | Фармакокинетика и Фармакодинамика |
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| Online Access: | https://www.pharmacokinetica.ru/jour/article/view/386 |
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| author | E. V. Baskakov A. V. Grigorev A. A. Globenko A. G. Shmelev E. A. Kolmykova A. V. Yastrebova A. A. Sidorova A. V. Kapashin O. V. Kovchan A. I. Bashkatova M. A. Pasko |
| author_facet | E. V. Baskakov A. V. Grigorev A. A. Globenko A. G. Shmelev E. A. Kolmykova A. V. Yastrebova A. A. Sidorova A. V. Kapashin O. V. Kovchan A. I. Bashkatova M. A. Pasko |
| author_sort | E. V. Baskakov |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c957ff2caa6c4ffaaba5d4fcf7d2fa60 |
| institution | Kabale University |
| issn | 2587-7836 2686-8830 |
| language | Russian |
| publishDate | 2023-11-01 |
| publisher | LLC “Publisher OKI” |
| record_format | Article |
| series | Фармакокинетика и Фармакодинамика |
| spelling | doaj-art-c957ff2caa6c4ffaaba5d4fcf7d2fa602025-08-20T03:57:48ZrusLLC “Publisher OKI”Фармакокинетика и Фармакодинамика2587-78362686-88302023-11-01039410310.37489/2587-7836-2023-3-94-103349Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence studyE. V. Baskakov0A. V. Grigorev1A. A. Globenko2A. G. Shmelev3E. A. Kolmykova4A. V. Yastrebova5A. A. Sidorova6A. V. Kapashin7O. V. Kovchan8A. I. Bashkatova9M. A. Pasko10Yaroslavl regional clinical narcological hospitalCSU “Analytical Spectrometry”“Valenta Pharm” JSCYaroslavl regional clinical narcological hospitalГБУЗ ЯО «Ярославская областная клиническая наркологическая больница»CSU “Analytical Spectrometry”CSU “Analytical Spectrometry”“Valenta Pharm” JSC“Valenta Pharm” JSC“Valenta Pharm” JSC“Valenta Pharm” JSCAim. 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.https://www.pharmacokinetica.ru/jour/article/view/386gidazepampharmacokineticsbioequivalencebenzodiazepines |
| spellingShingle | E. V. Baskakov A. V. Grigorev A. A. Globenko A. G. Shmelev E. A. Kolmykova A. V. Yastrebova A. A. Sidorova A. V. Kapashin O. V. Kovchan A. I. Bashkatova M. A. Pasko Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study Фармакокинетика и Фармакодинамика gidazepam pharmacokinetics bioequivalence benzodiazepines |
| title | Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study |
| title_full | Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study |
| title_fullStr | Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study |
| title_full_unstemmed | Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study |
| title_short | Study of the pharmacokinetic profile of the medicinal product Gidazepam®, tablets, 50 mg in a bioequivalence study |
| title_sort | study of the pharmacokinetic profile of the medicinal product gidazepam r tablets 50 mg in a bioequivalence study |
| topic | gidazepam pharmacokinetics bioequivalence benzodiazepines |
| url | https://www.pharmacokinetica.ru/jour/article/view/386 |
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