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Drug-Drug Interaction of Pyrotinib With a Moderate CYP3A Inducer

NCT04680091 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-04-22

No results posted yet for this study

Summary

This drug-drug interaction (DDI) study had been designed to investigate the effect of a moderate CYP 3A inducer efavirenz on the pharmacokinetics of maleate pyrotinib in Chinese healthy volunteers.

Conditions

  • Healthy Subjects, Drug-drug Interaction, Pyrotinib

Interventions

DRUG

Pyrotinib Maleate

single oral dose, 400 mg, fed.

DRUG

Efavirenz

single oral dose, 600 mg, fasted, at bedtime.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2021-01-28
Completion
2021-12-30

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 NCT04680091 on ClinicalTrials.gov