MedTrace Logo

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

NCT05252546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05252546 on ClinicalTrials.gov