The effect of high-fat diet on the pharmacokinetics of ondansetron hydrochloride tablets in healthy Chinese subjects

This publication reports a bioequivalence study examining how a high-fat diet affects the pharmacokinetics and safety of 8 mg ondansetron hydrochloride tablets in 53 healthy Chinese subjects, comparing fasted and postprandial administration. Plasma concentrations were measured by LC-MS/MS and pharmacokinetic parameters derived using Phoenix WinNonlin. Ondansetron Cmax and AUC were significantly lower when taken with food, falling outside the standard bioequivalence range relative to fasted dosing, though adverse event rates were comparable between conditions. The findings indicate that a high-fat meal meaningfully reduces ondansetron absorption, while the drug remained safe and well tolerated in both fasted and fed states.