Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Group A:R-T
Group B: T-R
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female, age: 18-45 years old, including boundary value; 2. Male weight >= 50 kg, female weight >= 45 kg, body mass index (BMI) between 19-26 kg / m2 (BMI = weight (kg) / height 2 (M2)), including boundary value; 3. The subjects who voluntarily sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have or are currently suffering from any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system (such as asthma), hematology, immunology, psychiatry and metabolic abnormalities; (screening period). 2. Patients with chronic or active gastrointestinal diseases, such as esophageal disease, gastritis, gastric ulcer, diverticulitis, enteritis, active gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal surgery, within three years before the trial; (screening period). 3. Patients who are allergic to ibuprofen, other non steroidal anti-inflammatory drugs, food or other substances; (screening period). 4. Subjects who had undergone surgery within 4 weeks before the trial, or planned to undergo surgery during the study period; (screening period). 5. Subjects who have used any drugs within 14 days before the trial (including Chinese herbal medicine and health care products); (screening period). 6. Subjects who had used any drugs that might inhibit or induce liver metabolism within 30 days before the trial (such as: inducer barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrocyclic esters, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) Class). (screening period) 7. Those who have been vaccinated within 30 days before the trial, or who plan to be vaccinated within 3 months after the trial. (screening period) 8. Subjects who participated in any other clinical trial within 3 months before the trial. (screening period consultation + online screening / check-in period) 9. Subjects who had donated blood or accidentally lost more than 200 ml of blood within 3 months before the trial. (screening period / admission period) 10. Those who have unprotected sexual behaviors within 2 weeks before screening, during the trial and 3 months after the trial, can not take one or more non drug contraceptive measures, or have plans for pregnancy, sperm donation and egg donation. (screening period / admission period) 11. Those who have special requirements on diet and can not follow the unified diet. (screening period) 12. Subjects who drink too much tea, coffee and / or caffeinated drinks every day (more than 8 cups, 1 cup = 250 ml), or those who do not agree to stop drinking during the trial. (screening period / check-in period). 13. Smokers or those who smoked more than 5 cigarettes per day within 3 months before the trial, or did not agree to stop smoking during the trial.(screening period / admission period) 14. Alcoholics or regular drinkers within 6 months before the trial, i.e. drinkers who drink more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml 40% alcohol or 150 ml wine), or who do not agree to stop drinking during the trial. (screening period / check-in period) 15. Drug abusers or those who used soft drugs within 3 months before the trial (such as cannabis) or those who used hard drugs within 1 year before the trial (such as cocaine, phencyclidine, etc.). (screening period) 16. Subjects with vasovagal syncope, poor venous condition or difficult puncture. (screening period) 17. Subjects with poor compliance, unable to complete the study due to other reasons, or the researchers think that they should not be included or continue to participate in the trial. (screening period / admission period) 18. Subj
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Bo'ai rehabilitation hospital
Outcome results
None listed