Bioequivalence
Conditions
Interventions
T---R:Test preparation (T)---Reference preparation (R)
R---T:Reference preparation (R)---Test preparation (T)
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age is over 18 years old, regardless of gender; 2. The body weight of male subjects was more than 50.0 kg, the body weight of female subjects was more than 45.0 kg, and the body mass index (BMI) was between 19 and 26 kg/m² (including the boundary value); 3. All subjects voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. patients who have had or are currently suffering from any clinically serious diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic abnormalities or any other diseases that may interfere with the test results (e.g., peptic gastric ulcer, duodenal ulcer, Helicobacter pylori infection, etc.); 2. Have a history of allergy to drugs, food or other substances, or any of the ingredients in this product; 3. Patients who had undergone surgery within 28 days before the trial or planned to undergo surgery during the trial; 4. Those who had taken any medicine or health products (including Chinese herbal medicine) within 14 days before the trial; 5. Those who used any clinical trial drug or enrolled in any drug clinical trial within 3 months before the trial; 6. Blood donors within 3 months before the trial, or those who lost more than 400 mL of blood within 3 months before the trial; 7. Oral contraceptive use within 30 days before the trial, or long-acting estrogen or progestin injection or implant use within 6 months before the trial; 8. Women who have had unprotected sex within 14 days before the trial, or who are pregnant or lactating; 9. Those who were unable to take one or more non-pharmacological contraceptive methods during the trial; 10. Patients with special dietary requirements, unable to follow a uniform diet or dysphagia; 11. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day within 3 months before the trial; 12. Have consumed or plan to consume any food or beverage containing caffeine (e.g., coffee, strong tea, chocolate, etc.) or xanthine rich food or beverage (e.g., sardines, animal liver, etc.) within 48 hours before the first dose of study drug; 13. Had consumed or planned to consume grapefruit or grapefruit-related citrus fruits (e.g., lime, grapefruit), star fruit, papagua, pomegranate, or more fruit products within 14 days before taking the first study drug; 14. Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the test; 15. Heavy drinkers or regular drinkers in the 6 months before the trial, i.e., consuming more than 14 units of alcohol per week (1 unit ˜200 mL of 5% beer or 25 mL of 40% spirits or 85 mL of 12% wine); 16. Drug abusers or those who had used soft drugs (such as cannabis) within 3 months before the test or hard drugs (such as cocaine, phencyhexidine) within 1 year before the test; 17. Patients with irregular bowel movements within 7 days before the test; 18. Patients with clinically significant abnormal vital signs [reference range: 90 mmHg= systolic blood press<140 mmHg, 60 mmHg= diastolic BP<90 mmHg, 60 beats/min = pulse =100 beats/min; Based on the judgment of the study physician], or if the findings of physical examination, electrocardiogram, or laboratory examination are clinically significant in the judgment of the study physician; 19. Those who fail a breathalyzer test or screen positive for substance abuse; 20. Persons who may not have been able to complete the trial for other reasons or who were considered by the investigator to be ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine;Adverse events;vital signs;Physical examination;ECG;Urine routine;Blood biochemistry;Coagulation function;Blood pregnancy test; | — |
Countries
China
Contacts
Public ContactYun Cai
Chinese PLA General Hospital
Outcome results
None listed