| Eligibility |
Inclusion Criteria:
- 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;
2.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);
4.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%;
6.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;
7.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.
Exclusion Criteria:
- 1.(Inquired) The subject has any of the following conditions: acute kidney failure, a
history of kidney transplantation, or a need for kidney transplantation or any type of
dialysis during the planned trial period; Patients with urinary incontinence or
anuria; Patients with obstructive urinary tract diseases (such as urinary tract
obstruction caused by urinary calculi, urinary tract obstruction caused by abdominal
space occupying lesions, etc.), and the investigator thought that they were not
suitable;
2. (Inquiry) In addition to the disease causing renal impairment, patients with
serious acute or chronic diseases of other vital organs within 1 year prior to
screening, including but not limited to diseases of the nervous system, cardiovascular
system, blood and lymphatic system, immune system, liver, gastrointestinal system,
respiratory system, metabolic system, skeletal system and other systems, who were
judged by the investigator to be not suitable for the trial;
3. (Inquiry) Any of the following occurred in the 6 months prior to study entry:
Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including
sustained ventricular tachycardia and ventricular fibrillation), right bundle branch
block and left anterior hemiblock (bifascicular block), Unstable angina pectoris,
coronary artery/peripheral artery bypass grafting, New York Heart Association (NYHA)
class III or IV congestive heart failure, cerebrovascular accident, transient ischemic
attack, or pulmonary embolism;
4. (inquiring) patients with a history of depression or suicidal tendencies;
5. (inquiry) patients who had severe gastrointestinal diseases or had digestive system
surgery within 3 months before screening, which affected drug absorption according to
the investigator;
6.(inquiry) blood loss or donation of more than 400mL within one month before
screening, or red blood cell transfusion;
7. Screening laboratory test results met any of the following: (a) alanine
aminotransferase (ALT) >2 times the normal value; (b) total bilirubin >1.5 times the
normal value; (c) neutrophil count <1.3×109/L; (d) hemoglobin <80g/L; (e) platelet
count <80×109/L;
8.(inquiry) with specific allergic history (asthma, urticaria, eczema, etc.), or
allergic condition (such as allergic to two or more drugs, foods or pollens), or known
allergic to PDE4 inhibitors (such as apast, roflumilast, etc.);
9. (queried) drug users in the past 3 years or drug abuse in the past 5 years;
10. screening positive for drug abuse (excluding those screened positive for drug
abuse due to concomitant medications);
11. with positive breath alcohol test (alcohol concentration >0mg/L);
12. (inquired) drank more than 14 units of alcohol per week in the 3 months before
screening (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44 mL of 40%
liquor or 147 mL of 12% wine), or could not abstain from alcohol during the study;
13.(inquired) smoked more than 5 cigarettes per day in the 3 months before screening,
or could not stop using any tobacco products during the study;
14. (questionnaire) consuming excessive amounts of tea, coffee and/or caffeine-rich
beverages (> 8 cups, 1 cup =250 mL) per day in the previous 3 months;
15. Hepatitis B, hepatitis C, HIV and syphilis tests have one or more clinical
significance;
16. (inquiry) who had participated in and used other drug/device clinical trials
within 3 months before screening;
17. (inquiry) use of any drugs (e.g., inductors-barbiturates, pioglitazone,
carbamazepine, phenytoin, glucocorticoids) that induce or inhibit hepatic
drug-metabolizing enzymes within 30 days before screening; Inhibitors: SSRI
antidepressants, cimetidine, diltiazem macrolides, nitroimidazole, sedative hypnotics,
verapamil, fluoroquinolones, antihistamines, isoniazid);
18. (inquiry) who had used prescription drugs, over-the-counter drugs, health
supplements, herbal products or vaccines other than those used to treat renal
impairment and other concomitant diseases within 2 weeks before screening;
19. (inquiry) consumed any caffeine/xanthine/food or drink (such as strong tea,
coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in
caffeine/xanthine/which may affect the absorption, distribution, metabolism, and
excretion of the drug in the investigator's decision from screening to -1 day of
admission, or could not stop consuming the above food or drink during the study;
20. (inquiry) pregnant or lactating women, or subjects (including male subjects) who
have plans to have children or to donate sperm or eggs from two weeks before the study
to six months after the last dose of the study, and who are unwilling or unable to use
effective contraception;
21.(inquiry) unable to eat or have swallowing difficulties, have special dietary
requirements and/or cannot follow a uniform diet;
22. (inquiry) with a history of epileptic seizures;
23. (inquiry) can not tolerate venipuncture and/or have a history of dizziness;
24.subjects with other factors considered by the investigator to be ineligible for the
trial.
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