ArticleFrontiers in pharmacology2025
Bioequivalence and safety assessment of sorafenib tosylate tablets in healthy Chinese subjects under fasting conditions.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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1 citing paper in PubMed.
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5 authors.
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Abstract
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 non-compartmental method. Safety was assessed on the basis of the occurrence of adverse events and laboratory findings throughout the study period. Results: The GMR point estimators of C Conclusion: The T formulation was bioequivalent and showed a similar safety profile to the R formulation Nexavar Clinical trial registration: http://www.chinadrugtrials.org.cn/index.html, Identifier CTR20233578.
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