NCT05252546

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

A Single-centre, Open, Single-dose, Fixed-sequence Study to Investigate the Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with each drug will also be assessed.

Conditions

• HER2-positive Recurrent / Metastatic Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-08
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2022-02-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: China