Effect of Itraconazole on the Pharmacokinetics of Apatinib

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT02836171
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Apatinib Mesylate Tablets — DRUG
    apatinib was administered in the morning after an overnight fast of at least 10 h
  • Itraconazole Capsules — DRUG
    rifampicin was administered in the morning 0.5 hours after breakfast

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
Jul 2016
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    subjects receiving a single 250 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then Itraconazole capsules 100 mg/day orally for 6 days with a single 250 mg oral dose of apatinib mesylate tablets co-administered on day 4 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h

Primary Outcome Measure

Area under the plasma concentration versus time curve (AUC) of Apatinib [ Time Frame: 0~72h after apatinib administration ]

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