drugset / Trial / NCT04315493

Effect of Low-fat Diet on the Pharmacokinetics of Pyrotinib in Healthy Participants

NCT04315493

Phase 1 Unknown 16 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedCrossoverOpen-labelBasic science

Summary

The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets. The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.

Timeline

Start
2020-03
Primary completion
2020-03
Completion
2020-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule Oral

Indications

No indication recorded.