This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
SHR6390 tablet single dose、Omeprazol single dose.
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Cmax
Maximum observed serum concentration (Cmax) for SHR6390 after Single dose.
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
AUC0-t
Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
AUC0-∞
Area under the plasma concentration versus time curve (AUC0-∞) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Tmax
Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
T1/2
Time to elimination half-life (T1/2) for SHR6390 after Single dose.\[Time Frame
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
CL/F
Apparent oral clearance (CL/F) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Vz/F
Apparent Volume of Distribution (Vz/F) SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
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Number of subjects with adverse events and severity of adverse events
Time frame: from Day1 to Day30 after the first dose