This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Subjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg\*3)
subjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg\*2+20mg\*2).
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China
Fr
Fr=AUC (test formulation)/AUC (reference formulation)
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Cmax
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
AUC0-t
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
AUC0-∞
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Tmax
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
T1/2
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Vd
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
CL/F
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Time frame: From the screening to the scheduled last visit day (Day 49±1 after dosing)
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