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A Food Effect Study of Apatinib Mesylate in Healthy Subjects

NCT04341090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-10-22

No results posted yet for this study

Summary

The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects.

The secondary objective of the study was to assess the safety of apatinib mesylate administered in adult healthy subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

Apatinib Mesylate

Single dose of apatinib mesylate after high-fat meal, low fat meal and fast

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2020-07-06
Completion
2020-07-06

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 NCT04341090 on ClinicalTrials.gov