Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04390984
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate, Gefitinib — DRUG
    Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.

Study Details

The primary objective of the study was to assess the effect of gefitinib on the pharmacokinetics of apatinib mesylate in lung cancer patients. The secondary objective of the study was to assess the pharmacokinetics of gefitinib, and to assess the safety of apatinib mesylate and gefitinib administered in lung cancer patients.

Key Dates

Start date
May 26, 2020
Status verified
Jan 2021
Primary completion
Feb 28, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.

Primary Outcome Measure

Cmax [ Time Frame: 0-24 hours ]

Central Contacts

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