This is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A single intravenous dose of 0.8 μg/kg HSK21542 in boluses after D1 dialysis completed.
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China
Cumulative recovery of unchanged drug (Ae)
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Time frame: From the start of administration to 168 hours after administration
Cumulative recovery fraction of unchanged drug (Fe)
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Time frame: From the start of administration to 168 hours after administration
Plasma clearance
The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate
Time frame: From the start of administration to 168 hours after administration
Cmax
The pharmacokinetic parameters of HSK21542 in plasma
Time frame: From the start of administration to 168 hours after administration
AUC(0-t)
The pharmacokinetic parameters of HSK21542 in plasma
Time frame: From the start of administration to 168 hours after administration
AUC(0-∞)
The pharmacokinetic parameters of HSK21542 in plasma
Time frame: From the start of administration to 168 hours after administration
Tmax
The pharmacokinetic parameters of HSK21542 in plasma
Time frame: From the start of administration to 168 hours after administration
t1/2
The pharmacokinetic parameters of HSK21542 in plasma
Time frame: From the start of administration to 168 hours after administration
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The main metabolites of HSK21542
The main metabolites of HSK21542 in plasma, urine, feces, and dialysate
Time frame: From the start of administration to 168 hours after administration
Adverse events (AEs)
The incidence and severity of AEs
Time frame: From after administration to the end of telephone follow-up