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Effect of Low-fat Diet on the Pharmacokinetics of Pyrotinib in Healthy Participants

NCT04315493 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-03-19

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets.

The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.

Conditions

  • Healthy Participants

Interventions

DRUG

pyrotinib maleate fasted in P1, low-fat diet in P2

pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2

DRUG

pyrotinib maleate low-fat diet in P1, fasted in P2

pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2020-03-31
Completion
2020-04-30

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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 NCT04315493 on ClinicalTrials.gov