The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
HRS9531 injection single dose.
Metformin Hydrochloride tablets 500mg.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days.
Time frame: Start of treatment up to 12 hours.
Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Maximum concentration (Cmax) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Terminal half-life (t1/2) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Clearance (CL/F) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Time to maximum concentration (Tmax) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
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Maximum concentration (Cmax) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration (AUC0-t).
Time frame: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf).
Time frame: Start of Treatment up to 504 hours.
Terminal half-life (t1/2) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Clearance (CL/F) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Apparent volume of distribution (VzF) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Incidence and severity of adverse events.
Time frame: Screening period up to 42 days.