The purpose of this study is to evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Area under the acetaminophen plasma concentration-time curve
Time frame: From time 0 to 24 hours after a single dose.
Maximum observed acetaminophen concentration
Time frame: From time 0 to 24 hours after a single dose.
Time of maximum observed acetaminophen concentration
Time frame: From time 0 to 24 hours after a single dose.
Area under the metformin plasma concentration-time curve
Time frame: From time 0 to 12 hours after the last of 7 repeated doses.
Area under the S-warfarin plasma concentration-time curve
Time frame: From time 0 to 168 hours after a single dose.
Area under the atorvastatin plasma concentration-time curve
Time frame: From time 0 to 72 hours after a single dose.
Area under the digoxin plasma concentration-time curve
Time frame: From time 0 to 120 hours after a single dose.
Area under the concentration versus time curve of acetaminophen from 0 to infinity
Time frame: Start of treatment up to 168 hours.
Apparent volume of distribution of acetaminophen
Time frame: Start of treatment up to 168 hours.
Time of maximum observed metformin concentration after 3.5 days of treatment
Time frame: Start of Treatment up to 30 hours.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atorvastatin
Digoxin
HRS9531
Clearance of metformin after 3.5 days of treatment
Time frame: Start of Treatment up to 30 hours.
Apparent volume of distribution of metformin after 3.5 days of treatment
Time frame: Start of Treatment up to 30 hours.
Time of maximum observed S-warfarin concentration
Time frame: Start of Treatment up to 168 hours.
Clearance of S-warfarin
Time frame: Start of Treatment up to 168 hours.
Apparent volume of distribution of S-warfarin
Time frame: Start of Treatment up to 168 hours.
Time of maximum observed atorvastatin (and its active metabolites) concentration
Time frame: Start of Treatment up to 72 hours.
Clearance of atorvastatin (and its active metabolites)
Time frame: Start of Treatment up to 72 hours.
Time of maximum observed digoxin concentration
Time frame: Start of Treatment up to 120 hours.
Maximum observed digoxin concentration
Time frame: Start of Treatment up to 120 hours.
Clearance of digoxin
Time frame: Start of Treatment up to 120 hours.
Apparent volume of distribution of digoxin
Time frame: Start of Treatment up to 120 hours.
Time of maximum observed HRS9532 concentration
Time frame: Start of Treatment up to 168 hours.
Maximum observed HRS9531 concentration
Time frame: Start of Treatment up to 168 hours.
Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration
Time frame: Start of Treatment up to 168 hours.
Area under the concentration versus time curve of HRS9531 from 0 to infinity
Time frame: Start of Treatment up to 168 hours.
Incidence and severity of adverse events
Time frame: Screening period up to 117 days.