drugset / Trial / NCT05252546

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

NCT05252546

Phase 1 Completed 36 enrolled Jiangsu HengRui Medicine Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-03-08
Primary completion
2022-08-02
Completion
2022-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Loperamide Small molecule 2 mg Oral
Subject Montmorillonite Power Unknown 3 g
Subject Pyrotinib Small molecule 400 mg Oral