None
Conditions
Interventions
Feding Group A (TR):One tablet of the test preparation was taken orally after meals in the first cycle, and one tablet of the reference preparation was taken after meals in the second cycle.
Feding Group B (RT):Take 1 tablet of reference preparation orally after meals in the first cycle and 1 tablet of test preparation after meals in the second cycle.
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) The subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, voluntarily serve as subjects, and sign the informed consent approved by the Ethics Committee; 2) Healthy male and female subjects over 18 years old (including 18 years old), with appropriate sex ratio; 3) Male weight =50.0kg, female weight = 45.0 kg; Body mass index (BMI) is in the range of 19.0~26.0kg/m2 (including critical value); 4) Vital signs examination, the reference value range: systolic blood pressure 90~139mmHg (including the boundary value), diastolic blood pressure 60~89mmHg (including the boundary value), pulse 60~100 beats/min (including the boundary value), body temperature 36.0~37.0? (including the boundary value), and the research doctor judges that there is no abnormality or abnormality without clinical significance. 5) Subjects (including male subjects) have no birth plan from 1 month before screening to 6 months after the end of the trial, and have no plans to donate sperm or eggs and voluntarily take effective contraceptive measures; 6)The subjects voluntarily signed the informed consent form, and were able to communicate well with the researchers and understand and abide by the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) The subject has a history of chronic or serious diseases of cardiovascular system, respiratory system, digestive system, genitourinary system, blood and lymphatic system, endocrine system, immune system, mental/nervous system, skeletal muscle and skin (consultation); 2) Those who are known to have allergic history to amlodipine, benazepril or other angiotensin converting enzyme inhibitor (ACEI) drugs, or their auxiliary materials, or have allergic history to drugs or foods in the past; 3) Those with a history of drug-dependent edema, vascular edema and facial edema; 4) Have a history of dysphagia or any gastrointestinal diseases that affect drug absorption; 5) People who are lactose intolerant (drinking milk and diarrhea) or have special requirements for diet and cannot accept a unified diet; 6) Those who can't tolerate venipuncture, those who have a history of fainting needle and blood, or those who have difficulty in venous blood collection; 7) Female subjects are breast-feeding or have positive pregnancy test results; 8) Laboratory examination (blood analysis, urine analysis+urine sediment quantification, blood biochemistry, virology examination and coagulation), physical examination, 12-lead electrocardiogram, chest X-ray and renal artery ultrasound examination, and the results judged by the researchers are abnormal and have clinical significance; 9) Those who have undergone surgery within 6 months before screening or are scheduled to undergo surgery during the trial, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs; 10) Those who have used drugs within 3 months before screening or have a history of drug abuse or have positive urine drug screening within 6 months before screening; 11) Those who donated blood or lost a lot of blood (=400mL) within 3 months before screening, received blood transfusion or used blood products; 12) Those who smoked more than 5 cigarettes per day within 3 months before screening or could not stop using any tobacco products during the test period; 13) Those who have consumed more than 14 units of alcohol per week (1 unit ˜357 mL beer or 43 mL liquor with 40% alcohol content or 147 mL wine with 12% alcohol content) in the three months before screening, or whose alcohol breath test results are more than 0mg/100ml, or who can't ban alcohol during the test; 14) Those who have participated in clinical trials of other drugs within 3 months before screening or those who have not participated in the trials themselves; 15) Those who have been vaccinated within one month before screening (special: COVID-19 adenovirus vector vaccine needs one month, inactivated and recombination vaccines needs two weeks), or those who plan to be vaccinated during the study period; 16) Alijilen, simvastatin, CYP3A4 inhibitor (such as ritonavir, indinavir, itraconazole, ketoconazole and clarithromycin), CYP3A4 inducer (such as enzalutamide, phenytoin sodium and rifampicin), lithium agent, gold agent and rapamycin target protein inhibitor (such as tissirolimus and everolimus) have been used within 28 days before screening. 17) Those who have taken any drugs, vitamins or health products orally within 14 days before screening; 18) Within 48 hours before screening, fruits or related products that affect metabolic enzymes such as grapefruit, grapefruit, pitaya and mango have been eaten; 19) Having eaten foods or drinks rich in caffeine (such as tea, chocolate and coffee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactBai Wanjun
Hebei General Hospital
Outcome results
None listed