None listed
Conditions
Interventions
Group TR:The test reagent was administered in the first cycle and the reference reagent in the second cycle
Group RT:The reference reagent was administered in the first cycle and the tested reagent was administered in the second cycle
Sponsors
Quannan County People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy adults aged 18-50 years (including 18 and 50 years); 2. Body mass index (BMI) : 19.0~28.0kg/m^2 (including 19.0 and 28.0 boundary values, BMI = weight/height ^2); 3. The results of a comprehensive physical examination, vital signs, 12-lead electrocardiogram and prescribed laboratory tests were normal or abnormal without clinical significance (as determined by the clinician), and the subjects were judged to be in good health and mental state by the investigator; Normal range of vital signs: (1) Sitting blood pressure: 90-140mmHg systolic blood pressure, 60-90mmHg diastolic blood pressure (including critical value); (2) Pulse: 60-100 times /min (sitting position, including critical value); (3) Body temperature: 36.0-37.3? (including boundary value); 4. Subjects should be willing to use appropriate contraceptive measures to avoid pregnancy or pregnancy to their partner during the period of study drug use and up to 3 months after withdrawal; 5. The subjects can communicate with the researchers smoothly, fully understand and strictly follow the study procedures, voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous history of drug allergy of clinical significance (especially known or suspected allergy to ibuprofen, aspirin or excipiants of this product or other NSaids) or history of atopic allergic diseases (such as asthmatic patients allergic to aspirin, urticaria, eczema dermatitis) or severe allergy; 2. Patients who have a history of fainting blood/fainting needle and cannot tolerate intravenous indwelling blood collection; 3. Patients who have been or are currently suffering from serious systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular, immune, urinary, digestive tract, liver, kidney and metabolic disorders or mental disorders; 4. Incorporation of diseases that may affect the interpretation of drug absorption, distribution, metabolism, excretion and safety data, or that may reduce adherence, including, but not limited to, any of the following: (1) A history of inflammatory bowel disease, peptic ulcers, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities; (2) A history of major gastrointestinal surgery (e.g., gastrectomy, gastrostomy, enterectomy, gastric bypass, gastrodissection, or gastric banding); (3) History or evidence of renal or renal impairment of clinical significance at the time of screening; (4) Evidence of liver disease or clinically significant liver function impairment at the time of screening; (5) Coagulation mechanism or platelet dysfunction (such as hemophilia) during screening; (6) Cardiac insufficiency, hypertension and so on during screening; 5. Positive human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or treponema pallidum antibody (Ant-TP); 6. Frequent drinkers in the 3 months prior to administration, i.e. drinking more than 2 units of alcohol per day (1 unit = 17.7 mL ethanol, i.e. 1 unit = 357 mL 5% alcohol beer or 43 mL 40% alcohol liquor or 147 mL wine with 12% alcohol); 7. Special diet (including dragon fruit, mango, grapefruit and/or xanthine, etc., products containing caffeine and alcohol, etc.), strenuous exercise or smoking, which may affect drug absorption, distribution, metabolism and excretion, etc., should not be prohibited during the trial period after taking the drug within 48 hours before administration or during the trial period; 8. Alcohol breath test positive; 9. Patients who have used prescription drugs, over-the-counter drugs, health medicines or live attenuated influenza vaccines (including COVID-19 vaccine) within 2 weeks before screening; 10. Patients who have used any drugs that inhibit or induce liver metabolism of drugs (e.g., inducers - rifampicin, barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.) or inhibitors - Fluconazole, SSRI antidepressants, cimetidine, macrolides, nitroimidazoles, verapamil, fluoroquinolones, antihistamines, etc.) within 30 days prior to administration; 11. Smoked an average of more than 5 cigarettes a day in the 3 months prior to administration or did not quit smoking throughout the study period; 12. Blood donors who donate or lose >=400mL of blood including blood components within the 3 months prior to administration, who receive blood transfusions or use blood products, or who cannot be banned for the duration of the trial and up to 1 week after the trial; 13. Consultation + online screening: Subjects who have participated in other clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the drug-time curve from zero to infinity;The area under the drug-time curve from zero to t;Peak concentration (Cmax); | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time (Tmax);Elimination half life (t1/2);Elimination rate constant (?z);Residual area percentage; | — |
Countries
China
Contacts
Public ContactTan Bingyan
Quannan County People's Hospital
Outcome results
None listed