Hypertension, coronary heart disease
Conditions
Interventions
fasting TR group:taking study drug under fasting condition, In the first period, the subjects were given a single dose of test formulation, in the second period, the subjects were given a single dose
fasting RT group:taking study drug under fasting condition, In the first period, the subjects were given a single dose of reference formulation, in the second period, the subjects were given a single
fed TR group:taking study drug under fed condition, In the first period, the subjects were given a single dose of test formulation, in the second period, the subjects were given a single dose of refer
fed RT group:taking study drug under fed condition, In the first period, the subjects were given a single dose of reference formulation, in the second period, the subjects were given a single dose of
Sponsors
Affiliated Hospital to Changchun University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Before the test, the subjects fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in the test and sign the informed consent. 2. Can complete research in accordance with the requirements of the program. 3. Subjects (including male subjestc) who do not plan to become pregnant and voluntarily use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the trial drug. 4. Healthy male or female, age 18 to 55 years, inclusive. 5. Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg, Body mass index (BMI) 19.0-28.0 kg/m^2, inclusive.
Exclusion criteria
Exclusion criteria: 1. Pre-existing neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic-renal insufficiency, endocrine, musculoskeletal disorders, or other disorders that, in the judgment of the investigator, may have an impact on drug metabolism or safety; 2. Abnormalities judged by the clinician to be clinically significant, including physical examination, vital signs examination, electrocardiogram, chest x-ray, or clinical laboratory tests; 3. Persons with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods), or allergies to amlodipine or excipients of the formulation; 4. History of dysphagia or any gastrointestinal disorder that interferes with drug absorption; 5. Lactose intolerant (e.g., those who have experienced diarrhea from drinking milk); 6. History of blood or needle sickness or inability to tolerate blood collection by venipuncture and known severe bleeding tendencies; 7. Previously or currently suffering from orthostatic hypotension; 8. A positive substance abuse screen or a history of substance abuse within the past 5 years; 9. Participation in another clinical trial of a drug within 3 months prior to screening; 10. Donated or lost = 400mL of blood (except for physiologic blood loss in women) within 3 months prior to screening, or who plan to donate blood or blood components during the study; 11. Consumed >14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits of 40% alcohol by volume or 150mL of wine) or a positive breath test for alcohol within 3 months prior to screening or who have consumed any alcohol-containing product within 48h prior to administration of study medication ; 12. Smoked mord than 5 cigarettes per day in the 3 months prior to screening or who have used any tobacco-based product in the 48h prior to taking study medication and during the trial; 13. Underwent surgery that would affect the absorption, distribution, metabolism, or excretion of the drug within 3 months prior to screening, or who plan to undergo surgery during the study period 14. Consumed excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months prior to Screening; 15. Used any drug that inhibits or induces hepatic metabolism of a drug (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; depressants-ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study drug; 16. Taked any medications or supplements (including herbal remedies) within 14 days prior to taking study drug; 17. Taked special diets (including fruits or related products that affect metabolic enzymes such as grapefruit, grapefruit, dragon fruit, mango, etc., foods or beverages rich in caffeine or xanthine such as coffee, tea, chocolate, etc.), or has had a significant change in exercise habits, in the 48h prior to administration of the study drug; 18. Unable to complete the trial for personal reasons; 19. The investigator considers the subject unsuitable to participate in the trial. In addition to the above requirements, female subjects shall also be excluded if they meet the following criteria: 20. the female subject is breastfeeding or has a positive pregnancy test result during the Screening Per
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events; | — |
Countries
China
Contacts
Public ContactHaimiao Yang
Affiliated Hospital to Changchun University of Chinese Medicine
Outcome results
None listed