CLINICAL TRIAL article
Front. Pharmacol.
Sec. Drug Metabolism and Transport
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1470095
Bioequivalence and safety assessment of sorafenib tosylate tablets in healthy Chinese subjects under fasting conditions
Provisionally accepted
- 1Laboratory of Clinical Pharmacokinetics, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, Nanjing, China
- 2China Pharmaceut Univ, Key Lab Drug Metab & Pharmacokinet, State Key Lab Nat Med, Nanjing 210009, Peoples R China, nanjing, China
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Objective: This study aimed to assess the bioequivalence and safety of two formulations of sorafenib in healthy Chinese subjects under fasting conditions Methods: A single-center, randomized, open, single-dose, two-formulation, four-period, crossover study was performed in 36 healthy Chinese subjects under fasting conditions. Blood samples were collected within 120 h after administration. The plasma concentrations of sorafenib were analyzed by a validated UPLC-MS/MS method, and pharmacokinetic parameters were analyzed using a noncompartmental method. Safety was assessed on the basis of the occurrence of adverse events and laboratory findings throughout the study period.The GMR point estimators of Cmax, AUC0-t, and AUC0-∞ for the two formulations were 88.97%, 81.67%, and 83.66%, respectively, which were within the bioequivalence criterion range of 80-125%. The upper limits of the one-sided 95% confidence intervals of Cmax, AUC0-t, and AUC0-∞ after logarithmic transformation were -0.05, -0.04 and -0.03, respectively, which were less than 0.The difference in Tmax between these two formulations was not statistically significant according to the Wilcoxon signed-rank test (P = 0.3650 > 0.05). Therefore, the bioequivalence between the two formulations was established under fasting conditions. All adverse events were mild and transient.The T formulation was bioequivalent and showed a similar safety profile to the R formulation Nexavar® (Bayer AG) in healthy Chinese subjects under fasting conditions Clinical trial registration: http://www.chinadrugtrials.org.cn/index.html, Identifier CTR20233578.
Keywords: Sorafenib, Bioequivalence, pharmacokinetic, UPLC-MS/MS, Safety
Received: 18 Oct 2024; Accepted: 01 Apr 2025.
Copyright: © 2025 Zhaoyu, hong, yun, Chen and Aa. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xijing Chen, Laboratory of Clinical Pharmacokinetics, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, Nanjing, China
Jiye Aa, China Pharmaceut Univ, Key Lab Drug Metab & Pharmacokinet, State Key Lab Nat Med, Nanjing 210009, Peoples R China, nanjing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
