Cardiovascular diseases
Conditions
Interventions
Part 2:enteric-coated sustained-release aspirin tablet 50mg
Part 2:enteric-coated sustained-release aspirin tablet 150mg
Part 1 sequence A:Three periods of treatment sequentially:enteric-coated sustained-release aspirin tablet 100mg a.c.,enteric-coated sustained-release aspirin tablet 100mg p.c.,enteric-coated aspirin t
Part 1 sequence B:Three periods of treatment sequentially:enteric-coated sustained-release aspirin tablet 100mg p.c.,enteric-coated aspirin tablet 100mg a.c.,enteric-coated sustained-release aspirin t
Part 1 sequence C:Three periods of treatment sequentially:enteric-coated aspirin tablet100mg a.c., enteric-coated sustained-release aspirin tablet 100mg a.c.,enteric-coated sustained-release aspirin t
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 44 Years
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 18-45 (including 18 and 45), including men and women; 2) Body mass index (BMI) between 19.0 and 26.0kg/m2 (including 19.0 and 26.0kg/m2), male subjects weighing =50kg, and female subjects weighing =45kg; 3) According to the subject's medical history, physical examination, blood routine, urine routine, blood biochemical examination and other laboratory tests and 12-lead electrocardiogram, the researcher judges that the subject's overall health is good; 4) Have the ability to communicate normally with medical staff and abide by the relevant management regulations of the hospital; 5) The subjects voluntarily sign the informed consent form approved by the ethics committee, and are willing and able to comply with all experimental requirements.
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy to the test drug or any of its components; 2) Those with a history of cardiovascular, liver, kidney, gastrointestinal, blood, mental and neurological diseases in the past or present; 3) Abnormalities in physical examination, vital signs, blood biochemistry, blood routine, urine routine, coagulation function, chest X-ray (front and side), ECG screening with clinical significance; 4) Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody; 5) People with long-term smoking, drinking, drug abuse and other bad habits (drinking: drinking more than 14 units (male) and 7 units (female) per week (1 unit = 360ml beer, or 150ml wine, or 45ml liquor); smoking: Smoking more than 5 cigarettes per day or ingesting the same amount of nicotine or nicotine substitutes); or those who cannot quit smoking or drinking during the trial; 6) People who are used to drinking coffee (daily consumption exceeds 450mg, about 85mg per cup); 7) Those who used any prescription or non-prescription drugs within 4 weeks before administration; 8) Those who lost more than 400ml (including 400ml) of blood due to donation, surgery or other factors within 3 months before screening; 9) Those who have participated in any clinical trials and used experimental drugs within 3 months before screening; 10) Those who have suffered from clinically significant diseases or have undergone major surgical operations within 3 months before the screening period; or have undergone operations that may affect drug absorption, metabolism, and excretion (such as gastrointestinal surgery) in the past 5 years; 11) Those who have suffered from kidney disease or urinary system disease that the investigator considers to be clinically significant within 2 years before screening; 12) Those who had a history of intractable constipation, hemorrhoids with bleeding, intestinal obstruction, gastric ulcer, reflux esophagitis, chronic gastritis, abnormal gastric acid secretion, inflammatory bowel disease, gallbladder disease, and pancreatic disease within 1 year before screening; 13) Those who cannot tolerate venipuncture blood collection, haemorrhage or have difficulty swallowing tablets; 14) Female subjects with a history of dysmenorrhea within the first 3 months of screening; 15) Fertile men (except those with bilateral vasectomy and unreversed vas deferens in the history of surgery) have plans to donate sperm within 2 weeks before screening to 6 months after the end of the trial, or do not use condoms or other methods to ensure that sexual partners are using effective contraception; 16) Women of childbearing age who are pregnant, breastfeeding or planning pregnancy, or do not use effective contraceptive measures during the trial (effective contraceptive measures refer to sterilization, intrauterine hormone devices, contraceptive pills/doses, abstinence or partner vasectomy) Women, or women who plan to donate eggs within 2 weeks before the screening to 6 months after the end of the trial; 17) Eat food that may affect the metabolism of the drug within 24 hours before taking the study drug (including grapefruit or grapefruit products, dragon fruit, mango, grapefruit, orange, xanthine diet, alcohol, caffeine, etc.), or other diets that may affect drug absorption, distribution, metabolism, and excretion judged by investigators; or those who do not agree to stop eating the above diets during the trial; 18) Any dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| T1/2;Tmax;?z;Vd;MRT;CL/F;physical examination;adverse events;vital signs;laboratory tests; | — |
Countries
China
Contacts
Public ContactKexin Li
Outcome results
None listed