Bioequivalence Analysis of Ondansetron Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Two-Period Crossover Phase I Study.

ABSTRACT:

Background

Ondansetron is a highly selective 5-HT3 receptor antagonist that alleviates nausea and vomiting. Bioequivalence evaluation ensures that the efficacy of generic drugs is consistent with that of the original drug.

Objective

The objective of this study was to evaluate the bioequivalence of ondansetron hydrochloride (HCl) tablets taken in single doses under fasting and postprandial conditions in healthy subjects.

Methods

In this randomized, open-label, two-cycle, crossover phase I study, liquid chromatography‒tandem mass spectrometry (LC‒MS/MS) was used to determine the ondansetron concentration in dipotassium-ethylenediaminetetraacetate (K₂-EDTA) plasma after the subjects received a single 8 mg of ondansetron and reference formulation. Twenty-six he

SUBMITTER: Jia C 

PROVIDER: S-EPMC11652556 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature