The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
SHR0302 tablets (10 mg)
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe maximum plasma concentration (Cmax) of SHR0302
up to 72 hrs postdose on day1 and day7
Time frame: up to 72 hrs postdose
The area under the plasma concentration-time curve (AUC) of SHR0302
up to 72 hrs postdose on day1 and day7
Time frame: up to 72 hrs postdose
The accumulative excretion rate of SHR0302 and its metabolites in urine and feces
up to 96 hrs postdose on day1 and day7
Time frame: up to 96 hrs postdose
The number of volunteers with adverse events as a measure of safety
required last visit via telephone during D11 to D21
Time frame: up to Day 21
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