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Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

NCT04479891 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-07-21

No results posted yet for this study

Summary

The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.

Conditions

  • Healthy Subjects

Interventions

DRUG

pyrotinib tablet

single oral dose of SHR6390 or co-administered with itraconazole

DRUG

Itraconazole capsule

200 mg itraconazole QD

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
2019-09-18
Primary Completion
2019-10-11
Completion
2019-11-30

Countries

  • China

Study Locations

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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 NCT04479891 on ClinicalTrials.gov