The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
HRS-1301 tablet, oral medication.
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Maximum concentration (Cmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Time of maximum concentration (Tmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Elimination half-life (t1/2).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Apparent clearance (CL/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Apparent volume of distribution (Vz/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
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Time frame: 0 hour to 8 days after dosing.
Cumulative drug excretion in urine (Ae,urine).
Pharmacokinetic parameters of HRS-1301 in urine.
Time frame: 0 hour to 6 days after dosing.
Cumulative drug excretion fraction in urine (fe,urine).
Pharmacokinetic parameters of HRS-1301 in urine.
Time frame: 0 hour to 6 days after dosing.
Incidence of adverse events (AEs).
Safety and tolerability.
Time frame: 0 hour to 8 days after dosing.
Incidence of serious adverse events (SAEs).
Safety and tolerability.
Time frame: 0 hour to 8 days after dosing.