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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
42
Single dose of apatinib mesylate after high-fat meal, low fat meal and fast
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cmax
Maximum Observed Plasma Concentration for apatinib \[ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours \]
Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
AUC0-t
Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib
Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
AUC0-inf
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib
Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
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