Microangiopathemia, chronic venous insufficiency (varicose vein syndrome) and sequelae
Conditions
Interventions
Test product-Reference product (fasting):The test preparation was taken orally on day 1 and the reference preparation was taken orally on day 8
Reference product - Test product (fasting):The reference preparation was taken orally on day 1, and the test preparation was taken orally on day 8
Test product-Reference product (postprandial):The test preparation was taken orally on day 1 and the reference preparation was taken orally on day 8
Reference product - Test product (postprandial):The reference preparation was taken orally on day 1, and the test preparation was taken orally on day 8
Sponsors
Cangzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent; 2. Healthy male or female subjects aged 18-65 years (including the critical value); 3. Male weight >= 55 kg, female weight >= 45 kg, body mass index (BMI) between 19.0 and 26.0 kg/m^2 (including the critical value); 4. Subjects (including partners) have no pregnancy plans and ensure appropriate contraceptive use within 2 weeks prior to the screening period and 6 months after the last dose; 5. Be able to fully understand the test process and possible adverse reactions and complete the test according to the program plan.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, allergic to drugs and food, known to be allergic to calcium oxybenzenesulfonate capsules drug ingredients; 2. History of mental illness, drug abuse, drug dependence; 3. Patients with diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism and skeletal system diseases; 4. Had a history of drug abuse in the 6 months prior to screening and had taken any drugs in the 14 days prior to the test; 5. Pregnant or lactating women, or those who had a positive blood pregnancy test prior to study administration, or were unable to use investigator-approved contraceptive methods during the study as directed by the investigator; 6. Those who have used drugs in the 3 months prior to screening, or whose urine tests are positive for drugs; 7. Participants who have participated in other drug clinical trials or participated in clinical trials other than themselves within 3 months prior to screening; 8. Patients with acute gastrointestinal disease or chronic gastritis in the 3 months before and during screening. 9. People who have donated blood including component blood or massive blood loss (>= 400 mL), received blood transfusion or used blood products within 3 months prior to screening; 10. Serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab) with positive results; 11. Those who consumed more than 14 units of alcohol per week (1 unit of alcohol is about 360 mL beer or 45 mL 40% spirits or 150 mL wine) in the three months prior to screening, or who could not abstain from alcohol during the test period; 12. Smokers who smoked more than 5 cigarettes per day in the 3 months prior to screening, or who could not stop using any tobacco products during the test period; 13. Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day in the 3 months prior to screening; 14. Those who have special dietary requirements and cannot finish the test meal; Or do not agree to follow the water schedule and postural restrictions during the test; 15. Physical examination, vital signs examination, laboratory examination (blood routine, blood lipid test, urine routine, blood biochemistry, serology, pregnancy test (female only), coagulation routine), 12-lead electrocardiogram examination were judged by the investigator to be abnormal, which may endanger the safety of the subject, or heart rate < 60 beats/min; 16. Long-term consumption of grapefruit-rich drinks or foods; Or had consumed any grapefruit-rich drinks or foods in the 48 hours before the first dosing; 17. People who have difficulty swallowing or any gastrointestinal disease or history of disease that affects the absorption of drugs; 18. Subjects may be unable to complete the study for other reasons or should not be included in the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;T1/2z;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYangrong Wang
Cangzhou Central Hospital
Outcome results
None listed