Evaluation of the pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib in healthy volunteers.

ABSTRACT:

Aims

To investigate the potential pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib.

Methods

This study was a single-center, open-label, single-dose, fixed-sequence clinical trial conducted with healthy volunteers. The participants were divided into two groups (A and B), each consisting of 18 subjects. Both groups received a single oral dose of 400 mg of pyrotinib on day 1. On day 9, Group A received a single dose of 400 mg of pyrotinib followed by 3 g of montmorillonite powder 2 h later, while Group B received a single dose of pyrotinib and 4 mg of loperamide after breakfast on day 9, followed by single oral doses of 2 mg of loperamide at 2 and 4 h post-administration. Blood samples were collected to determine pyrotinib blood concentrations.<

SUBMITTER: Wang Y 

PROVIDER: S-EPMC12104674 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature