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.
Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
Male or female subjects aged 18 to 65 (including 18 and 65);
Body mass index (BMI) ranges from 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min; Subjects with severe renal function impairment: 15~29 mL/min.
Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those allergic to any drug or food), or those known to be allergic to any component of the studied drug;
Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the pointed point, a history of clinically significant T-wave changes, myocardial infarction, or angina pectoris;
Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have been treated without recurrence signs and resected cervical intraepithelial neoplasia);
Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
Single group
HRS-1301 Tablet
DrugHRS-1301 tablet, oral medication.
Maximum concentration (Cmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
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.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time of maximum concentration (Tmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
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.
Elimination half-life (t1/2).
Pharmacokinetic parameters of HRS-1301 in plasma.
Apparent clearance (CL/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
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