hypertension, Chronic kidney disease
Conditions
Interventions
experimental group:Single dose group of levalamlodipine besylate tablets
Sponsors
the First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer as subjects, and sign the informed consent form before any research procedure begins, and guarantee that any procedure will involve me in the research; 2. Male and female subjects aged 18 to 60 years; 3. Weight: not less than 45kg for women, not less than 50kg for men; body mass index [= body weight kg/ (height m ^2 ) ^2 ] >= 19kg/m ^2 , and <= 28kg/m ^2 ; 4. Meet the diagnostic criteria for stage 3-4 chronic kidney disease (CKD): 15<=glomerular filtration rate (GFR)<= 59ml/(minx1.73m^2); 5. According to the diagnostic criteria of the 2018 revision of the Chinese Guidelines for the Prevention and Treatment of Hypertension, patients diagnosed with mild to moderate hypertension, namely: the average sitting blood pressure of the patients before enrollment (the systolic blood pressure was measured three times every 2 minutes after sitting for 5 minutes of rest) (SBP)/diastolic blood pressure (DBP), take the average value) as 140mmHg <= SBP < 180mmHg and/or 90mmHg <= DBP <110mmHg; 6. Patients with newly diagnosed hypertension who have not used any antihypertensive drugs; or have a history of hypertension, but the current blood pressure control is stable (systolic blood pressure <160mmHg and diastolic blood pressure <100mmHg) and have not used any antihypertensive drugs within one month. drug-pressing person; 7. The subjects can communicate well with the researcher, understand and comply with the requirements of this study, and are willing to stay in the Phase I clinical research ward as required.
Exclusion criteria
Exclusion criteria: 1. Allergies (multiple drugs or food allergies); or known history of allergies to study drug components or similar drugs; 2. In addition to renal damage and hypertension itself, acute diseases of any other organs and chronic diseases that affect the in vivo process of the research drug, such as severe heart failure (NYHA class III above), asthma, respiratory failure, diabetes mellitus with poor glycemic control (type 1 or 2, fasting blood glucose >=13.9mmol/L), history of thyroid disease causing changes in thyroid function, moderate to severe anemia (Hb < 60g/L) or Epilepsy, history of myasthenia gravis or other neuromuscular diseases, etc., may affect the in vivo process of the study drug and increase the risk of participating in the study; 3. Known coagulopathy; or known to have any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, and active pathological bleeding or Subjects with a history of intracranial hemorrhage; 4. Those who have undergone major surgical operations (except appendicitis) within 6 months before screening, or those who plan to undergo surgery during the study period; 5. Those who have used any drugs that inhibit or induce liver enzymes within 28 days before administration (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids; inhibitors - ketoconazole, omeprazole) azole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Use of drugs known to affect serum creatinine elimination (such as trimethoprim/sulfamethoxazole or cimetidine) within 2 weeks before administration, or use of drugs that competitively inhibit renal tubular secretion (such as propanesulfonic acid) Shu), or use of drugs that damage the kidneys, such as non-steroidal anti-inflammatory drugs; 7. Significant changes in the dosing schedule of prescription drugs and non-prescription drugs within 2 weeks before administration (the drug or dose adjustment is judged by the study doctor as may affect the stability of the patient's renal function or have additional effects on the distribution, metabolism, and excretion of the study drug); 8. During the trial, other drugs that may affect the absorption, distribution, metabolism, and excretion of the test drug need to be used in combination, and the investigators determine that they are not suitable for inclusion; 9. Those who participated in any clinical trial within 3 months before screening; 10. Those who lost blood or donated more than 200 mL of blood within 3 months before screening, received blood transfusion or used blood products; 11. Those with a history of needle fainting or haemorrhage, or those who cannot tolerate venipuncture for other reasons; 12. Those who drink excessive tea, coffee or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or do not agree to refrain from drinking tea, coffee and/or caffeinated beverages 24 hours before administration and during hospitalization drinker; 13. Alcoholics or frequent drinkers within 6 months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of 12% alcohol) wine); or those who do not agree to stop alcohol intake 24 hours before dosing and during hospitalization; or those who test positive for alcohol; 14. Smokers or those who smoked more tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak plasma drug concentration; | — |
Countries
China
Contacts
Public ContactLiu Jian, Chen Jianghua
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed