This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
SHR0302 Tablets once daily
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets single dose
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Cmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
AUC0-inf,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
Tmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
t1/2,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
CL/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
Number of subjects with adverse events and severity of adverse events
Time frame: Up to 35 days
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Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets once daily
Repaglinide Tablets single dose