healthy subjects
Conditions
Interventions
K-TR:Fasting state:Period ?-Test Preparation
Period ?-Reference Preparation
K-RT:Fasting state:Period ?-Reference Preparation
Period ?-Test Preparation
C-TR:Fed state:Period ?-Test Preparation
C-RT:Fed state:Period ?-Reference Preparation
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects over the age of 18 (inclusive), male or female; 2. The weight of the subject shall be no less than 50.0 kg for males and 45.0 kg for females, and the body mass index shall be within the range of 19.0~26.0 kg/m2 (including the critical value). Body mass index (BMI)=weight (kg)/height 2 (m2); 3. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 4. Those who can communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those who have participated in any other clinical trials or used research drugs in the merged group within 3 months before the trial; 2. Chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, diverticulitis, enteritis, active gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal surgery within three years; 3. Have respiratory system, cardiovascular system, endocrine system, nervous system, urinary system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities and other diseases or any other diseases that can interfere with the test results (such as biliary obstruction, left ventricular outflow tract obstruction, etc.), and are judged by the researcher to be abnormal and clinically significant; 4. Those who are allergic to the ingredients contained in this product and dihydropyridine derivatives or have allergic constitution; 5. Those who cannot tolerate venous puncture or have a history of blood sickness or needle sickness; 6. Those who have undergone surgery that the investigator judges will affect the absorption, distribution, metabolism and excretion of drugs within 6 months before the trial; Or received surgery within 4 weeks before the test; Or planned to perform surgery during the study period; 7. Those who have taken any medicine within 14 days before the test (including Chinese herbal medicine, health care products, prescription drugs, non prescription drugs, etc.); 8. Those who have used any drugs to inhibit or induce drug metabolism in the liver within 30 days before the test (such as inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin, Hypericum perforatum, etc.; inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, diltiazem, quinolones, pyrrole antifungal drugs, protease inhibitors, azole antifungal drugs, etc.); 9. Those who have been vaccinated with live vaccine or attenuated live vaccine within 2 weeks before the test, or plan to vaccinate these vaccines during the test; 10. Blood donors or those who lost a lot of blood (>400 mL) within 3 months before the test, those who received blood transfusion or used blood products, or those who planned to donate blood or blood components during the study period or within 3 months after the end of the test; 11. Those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; 12. Those who smoke more than 5 cigarettes a day within 3 months before the test, or cannot stop using any tobacco products during the test; 13. Those who have a history of alcohol abuse within 6 months before the test, that is, drink more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or unwilling to stop drinking or any alcoholic products during the test; 14. Those who drink too much tea, coffee and/or caffeinated drinks (more than 8 cups, 1 cup=250 mL) every day, or do not agree to stop drinking tea, coffee and/or caffeinated drinks during the test period; 15. Those who have special requirements for diet, cannot follow the unified diet or have difficulty swallowing, or are intolerant of lactose; 16. Female subjects who had unprotected sex within 14 days before the test, or were in pregnancy or lactation; 17. Those who have egg donation or sperm donation plans, or have fertility and pregnanc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactPingfei Fang
Department of pharmacy, Second Xiangya Hospital of Central South University
Outcome results
None listed