High blood pressure, Coronary heart disease
Conditions
Interventions
R-T group(fasting):In the first cycle, the subjects took the reference formulation (R) 10mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 5mg(1 tablet) o
R-T group(after meals):In the first cycle, the subjects took the reference formulation (R) 10mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 5mg(1 table
T-R group (fasting):Taking investigational drugs
T-R group (after meals):In the first cycle, the subjects took the test formulation (T) 5mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 10mg (1 ta
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand the purpose, nature, method and possible adverse reactions of the experiment, voluntarily act as a subject, and sign informed consent by myself before the start of any research procedure and guarantee that I will participate in the experiment during the whole process; 2.Male or female aged 18-55 years (including 18 and 55 years); 3.Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) in the range of 18.5~26.0kg/m^2 (including the critical value, BMI= weight (kg)/height (m^2)); 4.Have no pregnancy plan during the screening period and the next 3 months, voluntarily take effective contraceptive measures (Appendix 2), and have no sperm or egg donation plan; 5.Be able to communicate well with the researcher and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.People who are allergic to amlodipine or pharmaceutical excipiants (such as lactose), or are known to be allergic to any drug or food, or have a history of specific allergic reactions (such as asthma, rubella, eczema dermatitis) or are severely allergic, and are judged by the investigator to be clinically significant; 2.Have a history of dysphagia or any gastrointestinal disorder that affects drug absorption; 3.A history of any chronic or serious disease of the circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic abnormalities, or any other disease that may interfere with the results of the test, or a history of surgery within 3 months; 4.Have any medical condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and have a history of active pathological bleeding or intracranial bleeding; 5.Poor vascular puncture conditions, or can not tolerate venipuncture, or have a history of fainting needles and fainting blood; 6.A history of drug abuse in the six months prior to screening, or use of drugs in the three months prior to screening, including repeated, heavy use of narcotic drugs and psychotropic substances for non-medical purposes, Or urine addictive drugs morphine, methamphetamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis) screening test any one or more positive results; 7.Participants who had enrolled or were enrolled in another clinical trial within 3 months before screening; 8.Blood donation within 3 months before screening included blood components, massive blood loss (=400mL), transfusion or use of blood products; Or those who plan to donate blood (including blood components) during or within 3 months after the trial; 9.Use of prescription drugs, over-the-counter drugs, herbal medicines and vitamins within 14 days before screening; 10.Taking any drugs that alter liver enzyme activity or interact with amlodipine within 1 month before dosing; 11.Persons who were vaccinated within 3 months before screening or who were planning to be vaccinated during the trial; 12.Who smoked more than 5 cigarettes per day in the 3 months before screening, or who were unable to stop using any tobacco products during the trial; 13.Participants who consumed an average of more than 2 units of alcohol per day (1 unit =360 ml of beer, or 150 ml of red wine, or 45mL of distilled spirits) in the 3 months before screening, had a positive alcohol test, or did not agree to avoid alcohol during the trial; 14.Consuming excessive amounts of strong tea, coffee, and/or caffeinated beverages per day (> 8 cups, 1 cup =250mL) in the 3 months before screening; 15.People who have consumed strong tea, chocolate, coffee or foods or drinks containing caffeine, alcohol, xanthine (such as anchovies, sardines, beef liver, beef kidney, etc.), grapefruit (juice) or grapefruit (juice), orange, dragon fruit, mango, lime or star fruit within 48 hours before taking the drug; 16.Those who have special requirements for diet and cannot accept a uniform diet (such as intolerant to milk, eggs, butter, bacon and other foods); 17.Those with abnormal physical examination and vital signs judged by clinicians as clinically significant; 18.If laboratory tests (blood routine, urine dry chemistry and urine sediment quantification, blood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-72hr; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed