A randomized, open-label, two-period crossover study to evaluate the bioequivalence and food effect between two formulations of regorafenib in healthy adult participants.

ABSTRACT:

Background

This research aimed to compare the bioequivalence of a test formulation (regorafenib produced by Beijing SL Pharmaceutical Co., Ltd.) with a reference formulation (the original drug Stivarga^®) in Chinese healthy subjects under fasting conditions and two postprandial states: after low-fat and high-fat meals.

Methods

The research design was a randomized, open-label, two-period crossover trial involving a single 40 mg oral dose. Three separate studies were conducted. Study 1 enrolled 64 subjects who were dosed under fasting conditions; Study 2 involved 76 subjects dosed after a low-fat breakfast; and Study 3 also involved 76 subjects dosed after a high-fat breakfast. Plasma concentrations of regorafenib and M-2 were determined using a liquid chromatography

SUBMITTER: Li Y 

PROVIDER: S-EPMC11962789 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature