High blood pressure disease
Conditions
Interventions
A:The 12 subjects in the fasting group were randomly assigned to groups A and B according to Group A was randomly assigned to groups A and B, with 6 subjects in each group, and the order of administra
B:The 12 subjects in the fasting group were randomly assigned to groups A and B in the order of screening, with 6 subjects in each group and the order of administration in group B being R and T
C:The 12 subjects in the postprandial group were randomly assigned to either Group C or Group D in the order of screening, with 6 subjects in each group, and the order of administration in Group C was
D:The 12 subjects in the postprandial group were randomly assigned to either Group C or Group D in the order of screening, with 6 subjects in each group and the order of administration in Group D bein
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male or female healthy subjects; 2. Age: 18 to 65 years old (including borderline values); 3. Weight: male subjects should not be less than 50.0 kg and female subjects should not be less than 45.0 kg, with a body mass index [BMI = weight (kg)/height 2 (m2)] in the range of 19.0 to 28.0 kg/m2 (including borderline values); 4. Subjects must have given informed consent to the study prior to the trial and voluntarily signed a written informed consent form; 5. Subjects were able to communicate well with the investigator and were able to complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. Anyone who has had or is currently suffering from any clinically serious disease such as circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the test results; 2. Any history of drug, food or other substance allergy; 3. Anyone who has undergone any surgical procedure within 6 months prior to the trial; 4. Have taken any medications or supplements (including herbal medicines) within 14 days prior to the trial; 5. Have used any drugs that inhibit or induce hepatic metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial; 7. Those who donated blood or lost a significant amount of blood (>=200 mL, excluding women) within 3 months prior to enrollment blood loss during menstruation), receipt of blood transfusion or use of blood products within the 3 months prior to enrollment; 8. Pregnant or lactating women and those who are unable to use one or more non-pharmaceutical contraceptive measures during the volunteer trial; 9. Those with special dietary requirements who are unable to comply with a uniform diet; 10. Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day; 11. Tobacco users or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or were unable to stop using any tobacco products during the trial; 12. Alcoholics or those who were regular drinkers in the 6 months prior to the trial, i.e., consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine) or were unable to stop using any alcoholic products during the trial; 13. Substance abusers or those who used soft drugs (e.g., marijuana) in the 3 months prior to the trial or took hard drugs (e.g., cocaine, benzine) in the 1 year prior to the trial; 14. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or clinically significant abnormalities in physical examination, electrocardiogram, or laboratory tests (as determined by the clinician); 15. Volunteers who may be unable to complete the study for other reasons or who, in the opinion of the investigator, should not be included; 16. Those who have difficulty swallowing; 17. Those who cannot tolerate venipuncture, or who have a history of dizziness from needles or blood; 18. Those who have received a novel coronavirus vaccine within 28 days prior to the first dose, or who plan to receive a novel coronavirus vaccine during the study; 19. Those who have abnormal results of hepatitis B surface antigen, hepatitis C antibody, syphilis spirochete antibody (TP-trust), or HIV antibody tests Those with clinically significant abnormal results; 20. Those who have ingested any beverage or food rich in grapefruit or other ingredients that interfere with the absorption, distribution, metabolism, excretion, etc. of the drug within 48 hours prior to the first dose of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical Examination;Laboratory tests;Blood concentration;Adverse Events; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Outcome results
None listed