None listed
Conditions
Interventions
fasted T- R-T-R group:The subjects took the test preparation in the first cycle, the reference preparation in the second cycle, the test preparation in the third cycle, and the reference preparation i
fasted R-T-R-T group:The subjects took the reference preparation in the first cycle, the test preparation in the second cycle, the reference preparation in the third cycle, and the test preparation in
postprandial T- R-T-R group:In the postprandial state, the subjects took the test preparation in the first cycle, the reference preparation in the second cycle, the test preparation in the third cycle
postprandial R-T-R-T:In the postprandial state, the subjects took the reference preparation in the first cycle, the test preparation in the second cycle, the reference preparation in the third cycle,
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 48 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects over 18 years old, both male and female; 2. body weight >=50.0kg for men and >=45.0kg for women with body mass index (BMI) between 19.0 and 26.0kg/m^2 (including 19.0 and 26.0kg/m2) (BMI= weight/height^2); 3. have no plans to have children during the study and for at least 6 months after the last dose of study drug, voluntarily use effective contraceptive methods, and have no plans to donate sperm or eggs; 4. Able to communicate well with the investigators, understand and comply with the requirements of this study, and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Participants who participated in any drug clinical trial within 3 months before screening and used the study drug, or did not participate in the trial themselves; 2. patients with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, duodenal ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator; (for inquiry) 3. medical history of cardiovascular system, respiratory system, endocrine system, genitourinary system, nervous system, mental system, hematology, immunology, metabolic abnormalities, skin and bone, eye, ear, nose and throat, etc. (for inquiry) 4. A history of allergy to codeine, acetaminophen and oxycodone, allergic diseases, and asthma; Or a history of allergy to known drugs, biologics, or any ingredient in paracetamol and oxycodone product excipients; Or allergic constitution, or a history of allergy to food or other substances, or a history of allergic diseases (such as anaphylactic shock, angioedema, etc.), and the investigator believes that it is still clinically relevant; (for inquiry) 5. those who cannot tolerate vein puncture or have difficulty in blood collection, or have a history of syncope or syncope; (for inquiry) 6. patients who have undergone previous surgery that may affect the absorption, distribution, metabolism, and excretion of drugs according to the investigator's judgment; Or patients who had undergone surgery or biopsy within 3 months before screening or had major trauma and were judged by the investigator to be unsuitable for trial entry; If a surgical procedure was planned during the study or within 4 weeks of exit from the trial; (for inquiry) 7. those who had taken any medicine (including Chinese herbal medicine and health supplements) within 14 days before screening (inquiry); 8. use of any CYP3A4 or P-gp inhibitor (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, erythromycin, clarithromycin, dronedarone, HIV protease inhibitor (ritonavir), verapamil, diltiazem, amiodarone, cyclosporine, tacrolimus, and others) within 30 days before screening; Or CYP3A4 or P-gp inducers (rifampicin, phenytoin, carbamazepine, phenobarbitone, etc.), or CYP3A4 or P-gp substrates (midazolam, digoxin, atorvastatin, omeprazole, quinidine, etc.); (for inquiry) 9. History of bronchial asthma, chronic obstructive pulmonary disease, respiratory depression, hypercapnia; (for inquiry) 10. history of paralytic ileus; (for inquiry) 11. have or had habitual constipation; Patients with dysuria, difficult urination, and decreased urine flow; (for inquiry) 12. patients with irregular bowel movements or nausea and vomiting within 7 days before screening; (for inquiry) 13. with a long history of opioid use or dependence on opioids; (for inquiry) 14. Patients with a history of orthostatic hypotension: (inquiry) 15. who received a vaccine within 14 days before screening, or who plan to receive one during the trial; 16. those who had donated blood or lost a large amount of blood (=400mL) within 3 months before screening, received blood transfusion or blood products, or intended to donate blood or blood components during or within 3 months after the trial; 17. drug abusers or had used drugs within 1 year before the test, or had positive urine drug screening test (morphine, methamphetamine, ketamine); 18. smoker or had smoked more than 5 cigarettes per day in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax; AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;?z;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactSong Haojing
Hebei General Hospital
Outcome results
None listed