This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as probe drugs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
HRS5091 Tablets once daily
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets single dose
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Cmax,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
AUC0-∞,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
Tmax,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
t1/2,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
CL/F,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
Number of subjects with adverse events and severity of adverse events
Time frame: Up to 56 days
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Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets once daily
Digoxin Tablets single dose
Rosuvastatin Calcium Tablets single dose