NCT05252546View on ClinicalTrials.gov

Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 8, 2022

Primary Completion Date

August 2, 2022

Study Completion Date

August 2, 2022

Conditions
HER2-positive Recurrent / Metastatic Breast Cancer
Interventions
DRUG

pyrotinib tablet

single oral dose of pyrotinib or co-administered with Montmorillonite Power or Loperamide

DRUG

Montmorillonite Power

3 g or one pouch of montmorillonite power 2 hours after pyrotinib administration

DRUG

Loperamide

4 mg of loperamide with pyrotinib followed by 2mg every 2 hours for 2 times for a total of 8mg/day

Trial Locations (1)

410008

Xiangya Hospital Central South University, Changsha

All Listed Sponsors
lead

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY