The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Central hospital affiliated to Shandong first mecical university
Jinan, Shandong, China
Area Under the Concentration versus time curve (AUC) of HRS953
Time frame: Start of treatment up to Day 43
Maximum Concentration (Cmax) of HRS9531
Time frame: Start of Treatment up to Day 43
Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100%
Time frame: Start of Treatment up to Day 43
Time to maximum concentration (Tmax)
Time frame: Start of Treatment up to Day 43
Apparent terminal half-life (t1/2)
Time frame: Start of Treatment up to Day 43
Clearance (CL/F)
Time frame: Start of Treatment up to Day 43
Apparent volume of distribution (VzF)
Time frame: Start of Treatment up to Day 43
Incidence and severity of adverse events
Time frame: Screening period up to Day 43
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