Publication: Drugs in R&D
Abstract
This Phase I crossover study evaluated the bioequivalence of ondansetron hydrochloride tablets under fasting and postprandial conditions in healthy subjects, with plasma ondansetron quantified by LC-MS/MS and pharmacokinetic parameters calculated using Phoenix WinNonlin. Geometric mean ratios and 90% confidence intervals for Cmax and AUC measures fell within the standard 80-125% bioequivalence range under both fasting and fed conditions. The results confirm that the test and reference ondansetron formulations are bioequivalent in both fasted and fed states.
Author(s): Jia C, Zhao N, Song H, Hu Y, Xu Y, Guo C, Bai W, Dong Z
Published: 2024 年 10 月 29 日
Phoenix WinNonlin: Bioequivalence, Fasted and Fed
Phoenix WinNonlin's pharmacokinetic analysis confirmed bioequivalence for this ondansetron formulation across both fasting and fed conditions. Phoenix WinNonlin's results can flow directly into PK Submit for CDISC-compliant submission packages, within a Phoenix platform that has trained more than 9,000 people.
