microangiopathy
Conditions
Interventions
Fasting test TR group: One capsule of test preparation was taken orally on fasting in the first cycle, and one capsule of reference preparation was taken orally on fasting in the second cycle.
Fasting test RT group:One fasting reference preparation was taken orally in the first cycle, and one fasting test preparation was taken orally in the second cycle.
TR group was tested after meal:One capsule of test preparation was taken orally on fasting/after meal in the first cycle, and one capsule of reference preparation was taken orally on fasting/after mea
RT group was tested after meal:One fasting/postprandial reference preparation was taken orally in the first cycle, and one fasting/postprandial test preparation was taken orally in the second cycle.
Sponsors
Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects over 18 years old (including 18 years old), both male and female; 2. Weight index: male weight >=50kg, female weight >=45kg, 18<= BMI <=26. Bmi is calculated as follows: BMI (kg/m^2) = weight (kg)/height ^2 (m^2); 3. The subjects fully understand the content and process of the experiment and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a history of multiple and recurrent allergies, or have a history of allergies to any ingredient in the drug (indicating all excipients in the drug) or similar drugs; 2. Previous history of major diseases such as nervous system, cardiovascular system, liver, kidney, digestive system, respiratory system, blood system, immune system, metabolic disorders, benign/malignant tumors, or other diseases deemed unsuitable for clinical trials by the investigator; 3. Existing gastrointestinal and liver and kidney diseases that can affect drug absorption or metabolism; 4. Have a history of bleeding disorders or any medical history that may increase the risk of bleeding within the 6 months prior to screening; 5. Had previously undergone surgery that the investigators judged would affect drug absorption, distribution, metabolism, and excretion (including all patients who had partial resection of liver, kidney, gastrointestinal tract, etc., except appendectomy), or had undergone major surgery within 6 months before trial screening, or planned to undergo surgery during the study period; 6. A large number of blood donations (more than 400mL) or blood loss within 90 days before the first dose of the test; 7. Participated in any drug clinical trial and took medicine within 90 days before the first dose; 8. Use of any drug (including Chinese herbal medicine) for various reasons within 14 days before the first dose of the test; 9. Patients who have used any drug that inhibits or induces liver drug metabolism enzymes or other drugs with long half-life within 30 days before the first dose of the test; 10. Have a history of drug abuse or dependence, or have used drugs such as morphine, methamphetamine, ketamine, cannabis, ecstasy, etc. in the six months prior to screening; 11. Vaccination was given within 14 days before the first dose of the trial; 12. Smokers (more than 5 cigarettes per day on average), habitual chewers of betel nut or those who cannot accept the prohibition of using any tobacco products during the test; 13. Alcoholics: regular drinkers in the 6 months before the trial (i.e. drinking more than 14 units of alcohol per week, 1 unit =14g alcohol, equivalent to 360mL beer or 45mL spirits with 40% alcohol content or 150mL wine, equivalent to drinking 10 bottles of beer or 1 catty of white wine or 3 bottles of red wine per week); 14. Those who have consumed alcohol within 48 hours before the first dose, or whose alcohol breath test results are > 0.0mg/100mL on the day of the first check-in, or who are unwilling to accept the prohibition of drinking alcohol or consuming any products containing alcohol during the test; 15. Long-term intake of excessive tea, coffee and/or food or drink containing caffeine (including theophylline, caffeine, theobromine), grapefruit (average more than 8 cups per day, 1 cup =250mL); Do not accept any beverage or food containing tea, coffee and/or caffeine (such as strong tea, coffee, chocolate, cocoa, etc.), rich in xanthine or grapefruit during the 48 hours before taking the drug until the end of the trial; 16. People who have special requirements for diet, can not comply with a unified diet or swallowing difficulty, or are lactose intolerant; 17. Pregnant or lactating women, female subjects of childbearing age had unprotected sex with their partners within 2 weeks before screening; 18. A history of needle fainting, blood fainting, or difficulty in venous blood collection and/or inability to tolerate venipunction/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactShen Hongping
Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Outcome results
None listed