This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
West Hospital, Sichuan University
Chengdu, Sichuan, China
The maximum plasma concentration (Cmax) of hetrombopag
Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
Time frame: 0h-120h
The area under the plasma concentration-time curve (AUC) of hetrombopag
AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
Time frame: 0h-120h
The accumulative excretion rate of hetrombopag and its metabolites in urine and feces
Time frame: 0h-120h
The change of platelet count
Time frame: On day 2, 4, 6, 8,12, 14 and 16
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 16
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