hypertension
Conditions
Interventions
Sequence B:The first and third cycles of taking the reference preparation (R: Fulitan) ?) Take the test preparation (T: Alisartan medoxomil amlodipine tablets) in the second and fourth cycles.
Sequence A:The first and third cycles of taking the test preparation (T: Alisartan medoxomil amlodipine tablets)
Second and fourth cycles of taking the reference formulation (R: Fulitan) ?).
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions of the trial, and voluntarily sign a written informed consent; 2. Subjects can communicate well with investigators and complete the trial in accordance with the protocol; 3. The participants (including their partners) are willing to voluntarily use an effective contraceptive method from screening until 6 months after the last dose of study drug; 4. Age: 18-45 years old (including 18 and 45 years old); 5. Body weight: the body weight of male subjects is not less than 50 kg, the body weight of female subjects is not less than 45kg, and the body mass index [BMI= weight (kg)/height^2 (m^2)] is within the range of 19.0~26.0kg/m^2 (including the boundary value).
Exclusion criteria
Exclusion criteria: 1. Known allergic history to alisartan, amlodipine or similar drugs; Or allergic (e.g. people allergic to two or more medicines, foods such as milk and pollen); 2. Abnormal physical examination with clinical significance; 3. Abnormal vital signs with clinical significance; 4. ECG abnormalities with clinical significance; 5. Abnormal clinical laboratory tests with clinical significance; 6. Suffering from the following serious diseases, including but not limited to liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, lung, tumor, immune, skin, or blood related diseases; 7. Hepatitis B surface antigen positive, or hepatitis C virus antibody positive, or treponema pallidum specific antibody positive, or human immunodeficiency virus antibody positive; 8. patients who underwent major surgery within 6 months before screening; 9. Drug abuse history in the past 5 years, or drug use in the past 3 months before screening, or urine drug screening [morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinol] positive during screening, or habitual use of any drugs, including Chinese herbal medicine; 10. Participants who smoked more than 5 cigarettes per day in the 3 months before screening, smoked within 48 h before the first dose of study medication, or disagreed to avoid using any tobacco products during the study; 11. Regular drinkers in the 6 months before screening, i.e., consuming more than 14 units of alcohol per week (1 unit =360 mL of 5% beer or 45 mL of 40% spirits or 150 mL of 12% wine) or within 48 h before the first study dose or with a positive alcohol breath test at screening; Or unable to stop alcohol consumption during the study period; 12. Blood donation or massive blood loss (>=200 mL) within 3 months before screening; 13. Use of any drugs that alter CYP3A4 enzyme activity (e.g., inductors-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, azole antifungals); Or used any prescription medication, over-the-counter medication, any vitamin product, or herbal medicine within 2 weeks before taking the first study medication; 14.Consuming foods or beverages containing caffeine and/or rich in xanthine and/or grapefruit or grapefruit juice within 48h before the first dose of the study drug or not consents to administration of the first cycle of the drug until 96h after administration of the fourth cycle Sour drinks, cola, grapefruit or grapefruit juice); 15. Those who took a study drug within 3 months before the first dose of study drug or participated in a drug clinical trial and took the corresponding trial drug; 16. Patients with dysphagia; 17. Patients with any history of gastrointestinal diseases affecting drug absorption; 18. Those who have special requirements for diet and cannot abide by the uniform diet; 19. Acute illness occurred from the time of signing the informed consent to the time of taking the study drug; 20. Vaccinated within 3 months before screening; 21. Abdominal color Doppler ultrasound or chest X-ray with clinical significance; 22. Pregnant or lactating women; 23. Patients with a history of dizziness, dizziness, or can not tolerate venipuncture, or difficult to collect blood; 24. Subjects may not be able to complete the study for other reasons or should not be included in the study in the opinion of the inve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests;Vital signs;A 12-lead electrocardiogram was obtained;Tmax;Adverse events; | — |
Countries
China
Contacts
Public ContactZhihong Xie
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed