None
Conditions
Interventions
group A:Period 1:aspirin enteric-coated tablets 100 mg (1 tablet),a.c., administered orally once daily, for 10 days
Period 2:aspirin enteric-coated sustained release tablets 50 mg,p.c., administered orally once daily, for 10 days
group B:Period 1: aspirin enteric-coated sustained release tablets 50 mg,p.c., administered orally once daily, for 10 days
Period 2: aspirin enteric-coated tablets 100 mg (1 tablet),a.c., administered orally once daily, for 10 days
Sponsors
Beijing Luhe Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, methods and possible adverse reactions of the test, and voluntarily sign the written informed consent form; 2. Age at the time of signing the informed consent form: 18-45 years old (including boundary values); 3. Body mass index: 19.0-26.0 kg/m^2 (including boundary values), male subjects weighing >=50 kg; 4. Subjects are able to communicate well with the investigator and understand and comply with all the regulations required for this study; 5. The subject should not plan to have children and voluntarily use effective contraception (see Annex 1 of the trial protocol) within 3 months after the signing of the informed consent form and the last dose of the test drug, and should not plan to donate sperm, and should voluntarily use non-pharmacological contraception during the trial period.
Exclusion criteria
Exclusion criteria: 1. Those with a history of allergy to aspirin and any of the components of the test drug, a history of allergy to other drugs, a history of food allergy, or one of the conditions of anaphylaxis; 2. History of asthma, urticaria, or anaphylactic reactions induced by the use of aspirin or other non-steroidal anti-inflammatory drugs; 3. Those with previous or current severe cardiovascular (especially concerned with severe heart failure), hepatic, renal or urinary tract, gastrointestinal (especially concerned with active peptic ulcers/bleeding), psychoneurological, coagulation disorders, or malignant neoplasms (except for those who, in the opinion of the investigator, can be enrolled in the study); 4. Those with abnormal and clinically significant screening period physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram; 5. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, anti-AIDS antibody or syphilis antibody; 6. Those who have had major surgery within 3 months prior to screening, or those who are scheduled to undergo surgery during the trial period up to 1 month after the end of the trial, or those who have undergone surgery that may affect the absorption, metabolism, or excretion of the drug (e.g., gastrointestinal surgery), except for those who are considered by the investigator to be eligible for enrollment; 7. Those with a history of substance abuse, or drug use within 3 months prior to screening; or those with a positive urine drug abuse screen; 8. Those who have a history of chronic alcohol consumption (specifically: more than 14 units of alcohol per week, 1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of liquor), or a positive alcohol breath test screening result, and who are unable to abstain from alcohol for the duration of the trial; 9. Smoking habitual smokers, those who smoke more than 5 cigarettes per day or consume an equivalent amount of nicotine or nicotine substitutes, and who are unable to quit smoking during the trial period; 10. Habitual drinkers of grapefruit juice, tea, coffee and/or caffeinated beverages (>8 cups per day, 250 mL/cup) who are unable to stop drinking during the trial; 11. Persons who were vaccinated within 4 weeks prior to the first dose; 12. Anyone who used any prescription, over-the-counter, herbal, or vitamin within 2 weeks prior to the first dose; 13. Anyone who has used any medication that affects hepatic enzyme activity within 4 weeks prior to the first dose (see Annex 2 of the trial protocol); 14. Those who have lost more than 400 mL (including 400 mL) of blood due to donation, surgery, or other factors within 3 months prior to screening, or those who have received blood transfusions or used blood products; 15. Those who have participated in any clinical trial within 3 months prior to screening and have received drugs for testing or have used devices for testing; 16. Those with poor peripheral venous access, or a history of needle and blood sickness; 17. Those who have special dietary requirements and do not accept a uniform diet during the clinical study; 18. Those with dysphagia or any history of gastrointestinal disorders that affect drug absorption; 19. those with lactose intolerance (those who have experienced diarrhea from drinking milk); 20. those with toothache, headache, neuralgia, muscle aches and pains present within 4 weeks prior to drug administration, or those with previous recurrent acute or chronic pain; 21. Those who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet maximum aggregation rate;serum TXB2 levels;urinary 11-dehydro TXB2 levels;urinary 2,3-desmethyl-6-keto PGF1a levels;physical examination;vital signs;laboratory tests;12-lead electrocardiogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax; | — |
Countries
China
Contacts
Public ContactXuhong Wang
Beijing Luhe Hospital, Capital Medical University
Outcome results
None listed