Please use this identifier to cite or link to this item:
https://open.uns.ac.rs/handle/123456789/1299
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Viktorija Dragojević-Simić | en_US |
dc.contributor.author | Aleksandra Kovačević | en_US |
dc.contributor.author | Vesna Jaćević | en_US |
dc.contributor.author | Nemanja Rančić | en_US |
dc.contributor.author | Snežana Đorđević | en_US |
dc.contributor.author | Vesna Kilibarda | en_US |
dc.contributor.author | Momir Mikov | en_US |
dc.contributor.author | Dubravko Bokonjić | en_US |
dc.date.accessioned | 2019-09-23T10:14:47Z | - |
dc.date.available | 2019-09-23T10:14:47Z | - |
dc.date.issued | 2018-09-02 | - |
dc.identifier.issn | 17425255 | en_US |
dc.identifier.uri | https://open.uns.ac.rs/handle/123456789/1299 | - |
dc.description.abstract | © 2018, © 2018 Informa UK Limited, trading as Taylor & Francis Group. Background: The aim of the study was to evaluate the bioequivalence of two itraconazole 100 mg capsule formulations. Research design and methods: The single-center, open-label, randomized, three-period, three-sequence, reference-replicated, cross-over study included 38 healthy subjects under fed conditions. In each study period (separated by a 14-day washout), a single oral dose of the test (T) or reference (R) product was administered. Blood samples were collected at pre-dose and up to 72.0 h after administration. The calculated pharmacokinetic parameters, based on the plasma concentrations of itraconazole and hydroxy itraconazole, were AUC0-72h, AUC0-∝, Cmax, Tmax, T1/2 and Kel. Results: The 90% CI for the test/reference geometric means ratio for the parent compound, itraconazole, was in the range from 85.29% to 116.07% for AUC0-72h. Since the coefficient of variation (CV) for the reference product was 44.95% for Cmax, the 90% CI for this parameter for itraconazole was 93.49–133.78%, which was within the proposed limits of the EMA for bioequivalence of 72.15–138.59%. During the study, 4 subjects encountered a total of 14 mild adverse events. Conclusions: The use of the reference-scaling approach with 3-period design (TRR, RTR, and RRT) was an efficient way to demonstrate that two commercially available oral itraconazole formulations met the predetermined bioequivalence criteria. | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Expert Opinion on Drug Metabolism and Toxicology | en_US |
dc.subject | Itraconazole | en_US |
dc.subject | comparative bioavailability | en_US |
dc.subject | generic drugs | en_US |
dc.title | Bioequivalence study of two formulations of itraconazole 100 mg capsules in healthy volunteers under fed conditions: a randomized, three-period, reference-replicated, crossover study | en_US |
dc.type | Journal/Magazine Article | en_US |
dc.identifier.doi | 10.1080/17425255.2018.1503649 | - |
dc.identifier.pmid | 14 | - |
dc.identifier.scopus | 2-s2.0-85052146917 | - |
dc.identifier.url | https://api.elsevier.com/content/abstract/scopus_id/85052146917 | - |
dc.description.version | Published | en_US |
dc.relation.lastpage | 988 | en_US |
dc.relation.firstpage | 979 | en_US |
dc.relation.issue | 9 | en_US |
dc.relation.volume | 14 | en_US |
item.grantfulltext | none | - |
item.fulltext | No Fulltext | - |
Appears in Collections: | MDF Publikacije/Publications |
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