MedTrace Logo

A Drug-drug Interaction Trial of Loperamide Pharmacokinetics Effect on Pyrotinib Maleate

NCT04315116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-10-28

No results posted yet for this study

Summary

The primary objective of the study was to assess the effect of repeated oral doses of Loperamide on the pharmacokinetic profile of a single dose of Pyrotinib Maleate.

The secondary objective of the study was to assess the safety of Pyrotinib Maleate given alone versus Fluzoparib coadministered with Loperamide.

Conditions

  • Healthy Participants

Interventions

DRUG

pyrotinib maleate

a single oral dose of pyrotinib maleate on day 1 \& day10 .

DRUG

Loperamide

Loperamide 4 mg bid from day 7 to day 13

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-04-13
Primary Completion
2020-04-30
Completion
2020-09-01

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 NCT04315116 on ClinicalTrials.gov