"Aspirin is used to inhibit platelet adhesion and aggregation in patients with unstable angina pectoris, acute myocardial infarction, or regional ischemic cerebrovascular disorders when the gastrointestinal effects of aspirin are not tolerated."
Conditions
Interventions
Fast R-T Group:Participants took the reference formulation and the test formulation in the first and second cycles, respectively.
Fast T-R Group:The test formulation and the reference formulation were administered in the first and second cycles, respectively.
Fed R-T Group:Participants took the reference formulation and the test formulation in the first and second cycles, respectively.
Fed T-R Group:The test formulation and the reference formulation were administered in the first and second cycles, respectively.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy subjects, male and female (both male and female), aged 18 years and above (including 18 years old); 2. The body weight of male subjects should be at least 50.0kg, and the body mass index (BMI) should be at least 19.0-26.0 kg/m^2 (BMI= weight (kg)/height^ 2 (m^2)) (including the cut-off value); 3. The subjects (including male subjects) are willing to have no plans to have children within 6 months from screening to the last dose of study drug, voluntarily take effective non-drug contraceptive measures (see the Appendix), and have no plans to donate sperm or eggs; 4. Sign the informed consent before screening, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study in accordance with the requirements of the trial protocol. Those who did not meet any of the above conditions were not enrolled as subjects.
Exclusion criteria
Exclusion criteria: 1. Participants who have or are suffering from any disease requiring exclusion due to abnormal clinical manifestations before screening, including but not limited to the nervous/psychiatric system (e.g., epilepsy), respiratory system (e.g., aspirin asthma, bronchial asthma), cardiovascular and cerebrovascular system (e.g., hypertension), gastrointestinal system (any history or past history of gastrointestinal disease that interferes with drug absorption, and other diseases that require exclusion. Such as gastroesophageal reflux disease, gastrointestinal ulcer, functional dyspepsia, etc.), blood and lymphatic system (abnormal blood or past history, bleeding tendency or past history), liver and kidney function, endocrine system, immune system and other chronic or serious disease history, or any other diseases or physiological conditions that may affect the study results; 2. Participants‘ Vital signs, physical examination, clinical laboratory tests (blood routine, urine routine, blood biochemistry, stool analysis), four coagulation tests, four infection tests, pregnancy tests (only for women), 12-lead electrocardiogram and other tests, the results of which show clinically significant abnormalities; 3. Participants who used anticoagulants within 1 month before screening; 4. Participants who smoked an average of more than 5 cigarettes per day in the 3 months before screening, or who were unable to stop using any nicotine-containing products during the trial; 5. Participants who had consumed an average of more than 14 units of alcohol per week in the 3 months before screening or who were unable to abstain from alcohol during the trial; 6. Participants who consumed excessive amounts of tea, coffee and/or caffeinated beverages (> 8 cups per day, 1 cup ˜250mL) in the previous 3 months; 7. Participants with a history of drug abuse within 6 months before screening; 8. Participants who used drugs within 3 months before screening; 9. Participants who had undergone surgery within 3 months before screening or planned to undergo surgery during the study, and those who had undergone surgery that would affect the absorption, distribution, metabolism, and excretion of drugs; 10. Participants who had used any prescription drugs, over-the-counter drugs, Chinese herbal medicine or health care products within 2 weeks before screening; 11. Participants had used any drugs that inhibit or induce liver metabolism of drugs (e.g., inductors-barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole; Inhibitors-ssri antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 12. Participants who had participated in other drug clinical trials within 3 months before screening or did not participate in clinical trials by themselves; 13. Participants received a vaccination within 1 month before screening or plan to be vaccinated during the study; 14. Participants had blood donation within 3 months before screening included blood components or massive blood loss (=400mL); 15. Participants who cannot tolerate venipuncture or have a history of syncope or blood; 16. Participants with dysphagia; 17. Participants who have a clinical history of food or drug allergy, especially known to be allergic to aspirin, salicylic acid or any component of this product; 18. Participants with a history of lactose intolerance (those who have had cow's milk diarrhoea); 19. Participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;Safety Index;Ct;?z;t1/2z;AUC%Extrap; | — |
Countries
China
Contacts
Public ContactZhihong Xie
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed