The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.
This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg. For each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
SHC014748M Capsules: 200mg
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
AUC(0-t)
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.
Time frame: 72 hours
AUC(0-∞)
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity
Time frame: 72 hours
Cmax
Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration
Time frame: 72 hours
tmax
Pharmacokinetic of SHC014748M Capsules by assessment of time to Cmax
Time frame: 72 hours
AUC[%Extrap obs]
Pharmacokinetic of SHC014748M Capsules by assessment of AUC\[%Extrap obs\],the rate of AUC(t-∞) to AUC
Time frame: 72 hours
t l/2
Pharmacokinetic of SHC014748M Capsules by assessment of Terminal half life
Time frame: 72 hours
λz
Pharmacokinetic of SHC014748M Capsules by assessment of terminal rate constant
Time frame: 72 hours
CL/F
Pharmacokinetic of SHC014748M Capsules by assessment of apparent plasma clearance
Time frame: 72 hours
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Vz/F
Pharmacokinetic of SHC014748M Capsules by assessment of apparent volume of distribution
Time frame: 72 hours
MRT
Pharmacokinetic of SHC014748M Capsules by assessment of Mean Residence Time
Time frame: 72 hours