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Effect of Itraconazole on the Pharmacokinetics of Apatinib

NCT02836171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-02-27

No results posted yet for this study

Summary

he primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with itraconazole. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with itraconazole.

Conditions

  • Neoplasms

Interventions

DRUG

Apatinib Mesylate Tablets

apatinib was administered in the morning after an overnight fast of at least 10 h

DRUG

Itraconazole Capsules

rifampicin was administered in the morning 0.5 hours after breakfast

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen Yu · Shanghai Xuhui Central Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-02-28
Completion
2017-02-28

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 NCT02836171 on ClinicalTrials.gov