Pharmacokinetics and safety of the antitumor drug everolimus in healthy Chinese subjects: a single-dose, open-label, randomized, two-sequence, two-period crossover, phase I bioequivalence study
Rattachement africain : cn. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Purpose It aims to evaluate the pharmacokinetic (PK) similarity and safety of everolimus in whole blood under fasting and postprandial conditions and its generics in Chinese healthy subjects. Methods Healthy subjects were enrolled in a single-dose, open-label, randomized, two-sequence, two-period crossover study (Clinical trial registry number: CTR20220446) under fasting and postprandial conditions. The blood concentration of everolimus was quantified by a validated and robust liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results All 90% CIs for the geometric mean ratios of C max , AUC 0-t , and AU C 0 − ∞ were within the bioequivalence range of 80.00%–125.00%. the maximum intra-individual CV% of variation were 22.76% and 18.63% under fasting and fed conditions, respectively. The gastrointestinal absorption rate was decreased by food intake: median T max was 0.75 h in the fasted state, and 3.00 h after a high-fat meal. The average elimination half-life (t 1/2β , 37.19–38.43 h) and mean residence time (MRT, 23.13–25.81 h) did not appear to be affected by food intake regardless of fasting or fed state. In this study, no serious AE (SAEs) were observed throughout the trial. Conclusion The systemic availability of a single oral 5 mg dose of everolimus is significantly reduced by coadministration with fed compared with fasting conditions, the test formulation ( T ) and the reference formulation ( R ) were bioequivalent. Clinical Trial Registration clinicaltrials.gov , identifier CTR20220446, ( http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml ).
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
- Pharmacokinetics and safety of the antitumor drug everolimus in healthy Chinese subjects: a single-dose, open-label, randomized, two-sequence, two-period crossover, phase I bioequivalence study
- Date Crossref
- 18/12/2025
- Éditeur
- Frontiers Media SA
- 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
-
Nanchang University pays non établi dans la noticeUniversité ou école supérieure
-
First Affiliated Hospital of Jiangxi Medical College pays non établi dans la noticeÉtablissement de santé
-
Jiangxi Provincial Cancer Hospital pays non établi dans la noticeÉtablissement de santé
-
Second Affiliated Hospital of Nanchang University pays non établi dans la noticeÉtablissement de santé
-
Second Hospital of Nanchang pays non établi dans la noticeÉtablissement de santé
-
Jiangxi Cancer Hospital & Institute (The Second Affiliated Hospital of Nanchang Medical College) Clinical Medicine Research Center pays non établi dans la noticeUniversité ou école supérieure
-
Jiangxi Key Laboratory of Translational Research for Cancer pays non établi dans la noticeStructure de recherche
Nanchang University, First Affiliated Hospital of Jiangxi Medical College et Jiangxi Provincial Cancer Hospital, avec 4 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.