A Food Effect Study of Apatinib Mesylate in Healthy Subjects

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04341090
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Apatinib Mesylate — DRUG
    Single dose of apatinib mesylate after high-fat meal, low fat meal and fast

Study Details

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.

Key Dates

Start date
May 13, 2020
Status verified
Oct 2021
Primary completion
Jul 6, 2020
Completion
Jul 6, 2020

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Arm 1
    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after low-fat meal, the third dose will be after high-fat meal
  • Experimental: Arm 2
    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after fasted, the third dose will be after low-fat meal
  • Experimental: Arm 3
    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after high-fat meal, the third dose will be after fasted
  • Experimental: Arm 4
    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after high-fat meal, the third dose will be after low-fat meal
  • Experimental: Arm 5
    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after fasted, the third dose will be after high-fat meal
  • Experimental: Arm 6
    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after low-fat meal, the third dose will be after fasted

Primary Outcome Measure

Cmax [ Time Frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours ]

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