The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
The first affiliated hospital of sun yat-sen university
Guangzhou, China
RECRUITINGThe incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
To evaluate the safety and tolerability of repeated doses of SHR0410
Time frame: up to 7 days
Area under drug-time curve
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
peak time
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
peak concentration
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
half-life
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
apparent clearance rate
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
apparent distribution volume
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
The ratio of AUC0-t after the first and last administration.
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Time frame: up to 7 days
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