She Ding-Ping, He Ying, Li Ming-qu
Feb 27, 2023
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Journal
Biomedical chromatography : BMC
Abstract
Fluvoxamine is a selective serotonin reuptake inhibitor commonly used for various types of depression. The purpose of this study was to evaluate the pharmacokinetics and bioequivalence of fluvoxamine maleate tablets orally on an empty stomach and after a meal in healthy adult Chinese subjects, and to preliminarily evaluate their safety. A single-center, randomized, open-label, two-drug, two-period, crossover, single-dose trial protocol was designed. 60 healthy Chinese participants were enrolled and randomly classified into fasting(n=30) and fed group(n=30). Each week, subjects took fluvoxamine maleate tablets 50mg orally once as a test preparation or as a reference preparation on an empty stomach/after meals.. To evaluate the bioequivalence of test and reference tables, the concentration of fluvoxamine maleate in the plasma of the subjects at different time points after administration was detected by LC-MS; PK parameters including maximum plasma drug concentration (C), time to reach maximum concentration (T), area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC), and area under the plasma concentration-time curve from time 0 to infinity (AUC) were calculated. Our data revealed that 90% CIs of geometric mean ratio of the test or reference drugs for C, AUC, and AUC fell within the acceptance range for bioequivalence (92.30%~102.77%). The absorption, measured by AUC, did not have significant difference in both groups. There were no suspected serious adverse reactions or serious adverse events over the entire trial. Our results demonstrated that the test and reference tablets were bioequivalent under fasting and fed conditions.