To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild and Moderate Renal Impairment and Normal Renal Function After a Single Oral Administration
The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment.
• 1.Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;
⁃ adults of both sexes aged 18-70 years old (both ends, whichever is based on written informed consent);
• 3\. The body weight of male subjects was not less than 50 kg and that of female subjects was not less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
⁃ The creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) of the subjects met the CKD staging criteria of the corresponding groups, namely mild renal impairment: 60≤CLcr\<90 mL/min; Moderate renal impairment: 30≤CLcr\<60mL/min. At the same time, according to the investigator's judgment, the creatinine clearance rate of the subjects was not expected to change significantly by the end of the study.
• 5\. Stable renal function: the interval between two creatinine tests was at least 3 days (30 days before the first test result was acceptable), and the fluctuation value of serum creatinine results between the two tests (calculated by the formula: (the second result-the first result)/the first result) was less than 30%;
⁃ no new concomitant medications in the 2 weeks before screening, no adjustment in the treatment regimen (including the type, dose, or frequency of medications) for underlying diseases in the 4 weeks before screening, and no change in the treatment regimen (except for drugs used temporarily on demand) during the study (except as specified in the protocol), or no medication was used;
⁃ In addition to renal impairment and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, etc.), and no other clinically significant abnormalities.