This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
The maximum plasma concentration (Cmax) of SHR3824
Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
Time frame: Day 1-4 on visit 2 and visit 3
The area under the plasma concentration-time curve (AUC) of SHR3824
AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
Time frame: Day 1-4 on visit 2 and visit 3
The accumulative excretion rate of SHR3824 and its metabolites in urine and feces
Accumulative excretion rate will be compared under fating state and fasted state
Time frame: Day 1-4 on visit 2 and visit 3
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: Up to Day 12
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