Comparative analysis of bioequivalence, safety, and tolerability of semaglutide (tablets): results of an open-label randomized crossover comparative study
Rattachement africain : hr, ru, cz. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
The aim. To conduct a comparative evaluation of the physicochemical properties, biological activity, bioequivalence, and safety, including tolerability and immunogenicity, of the drug Semaltara® (semaglutide, tablets 3 and 14 mg (Biochemik, Russia) and the drug Rebelas® (semaglutide, tablets in dosages of 3 and 14 mg (Novo Nordisk A/S, Denmark) when administered to healthy volunteers. Materials and Methods. To assess the bioequivalence of the investigational drug Semaltara® (semaglutide, tablets 3 and 14 mg (Biochemik, Russia) with a chemically synthesized active substance to the original (reference) drug Rebelas® (semaglutide, tablets in dosages of 3 and 14 mg (Novo Nordisk A/S, Denmark), an open-label randomized crossover comparative study ( n = 110) was conducted. Patients were randomized into 4 groups: Group 1 ( n = 25) — patients received the investigational drug Semaltara® and the comparator drug Rebelas® daily once a day at a dose of 3 mg (1 tablet) for 28 days; Group 2 ( n = 25) — the comparator drug Rebelas® and the investigational drug Semaltara® daily once a day at a dose of 3 mg (1 tablet) for 28 days; Group 3 ( n = 30) — the investigational drug Semaltara® and the comparator drug Rebelas® daily once a day at a dose of 14 mg (1 tablet) for 28 days; Group 4 ( n = 30) — the comparator drug Rebelas® and the investigational drug Semaltara® daily once a day at a dose of 14 mg (1 tablet) for 28 days. The concentration of semaglutide was determined in serum samples using a pre-validated enzyme-linked immunosorbent assay (ELISA) method. The conclusion on bioequivalence of the compared drugs was made based on the assessment of 90 % confidence intervals for the ratios of geometric mean values of C max and AUC (0–t) parameters of semaglutide in the original units of measurement. Results. The results of the clinical study demonstrated the bioequivalence of the investigational drug and the comparator drug. The pharmacokinetic parameters of the drugs were comparable: Based on statistical analysis, the obtained 90 % confidence intervals for the ratio of C max,ss and AUC (0- τ )ss values of semaglutide 3 mg were 96.57–120.94 % and 94.37–120.06 %, respectively. For the 14 mg dosage, the 90 % confidence intervals for the ratio of C max,ss and AUC (0- τ )ss values of semaglutide were 91.79–109.68 % and 91.47–112.80 %, respectively. The tolerability of the drugs in volunteers was noted as good. No serious adverse events were registered during the entire study. Thus, the investigational drug Semaltara®, tablets, and the comparator drug Rebelas®, tablets, have a similar safety profile, including tolerability, at both the 3 mg and 14 mg dosages. Conclusion . The conducted study demonstrated the bioequivalence and similar safety profile, as well as tolerability of the Russian drug Semaltara® (semaglutide 3 and 14 mg, tablets, Promomed LLC, Russia) in comparison with the foreign drug Rebelas® (semaglutide, tablets in dosages of 3 and 14 mg (Novo Nordisk A/S, Denmark).
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Comparative analysis of bioequivalence, safety, and tolerability of semaglutide (tablets): results of an open-label randomized crossover comparative study
- Date Crossref
- 20/07/2026
- Éditeur
- Volgograd State Medical University
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Ministry of Health pays non établi dans la noticeOrganisme public
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National Research Mordovia State University pays non établi dans la noticeUniversité ou école supérieure
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Medical Technologies (Czechia) pays non établi dans la noticeEntreprise
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Tver State Medical University pays non établi dans la noticeÉtablissement de santé
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Volgograd State Medical University pays non établi dans la noticeUniversité ou école supérieure
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Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University pays non établi dans la noticeUniversité ou école supérieure
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Yaroslavl State Medical Academy pays non établi dans la noticeUniversité ou école supérieure
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Clinical Hospital No. 8 pays non établi dans la noticeÉtablissement de santé
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Russian Medical Academy of Continuing Professional Education pays non établi dans la noticeInstitution
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National Research Ogarev Mordovia State University pays non établi dans la noticeUniversité ou école supérieure
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Limited Liability Company “Center for Pharmaceutical Analytics” pays non établi dans la noticeEntreprise
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Russian University of Medicine pays non établi dans la noticeUniversité ou école supérieure
Ministry of Health, National Research Mordovia State University et Medical Technologies (Czechia), avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.