Enolic acid non-steroidal anti-inflammatory drugs, analgesic
Conditions
Interventions
test group one:Conduct a comparative study on the pharmacokinetics of QP001 injection 15 mg and Mobic 15 mg
test group two:QP001 injection fasting single dosing and multiple dosing
test group three:QP001 injection single dose on an empty stomach
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged 18 to 45 (including the critical value), half male and half male; 2. The weight of male volunteers is not less than 50 kg, and the weight of female volunteers is not less than 45 kg; the body mass index is in the range of 19~26 kg/m2 (including the boundary value). Body mass index (BMI) = weight (kg) / height 2 (m2); 3. Volunteers (including male volunteers) have no fertility plan, sperm donation or egg donation plan and voluntarily take effective physical contraceptive measures 30 days before the trial, during the trial and 90 days after the end of the trial; 4. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions. The volunteers can communicate well with the researcher, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. People with specific allergic diseases (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to two or more drugs, food or pollen, or known to be sensitive to the excipients and raw materials of this product (US). Loxicam) or other non-steroidal anti-inflammatory drugs (NSAIDs) allergy); 2. Those with the following serious diseases in the past, including but not limited to circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic disorders and other related diseases; 3. Those who have been vaccinated within 2 weeks before the trial, or who plan to be vaccinated during the trial; 4. Those who have been vaccinated within 2 weeks before the trial, or who plan to be vaccinated during the trial; 5. Those who have undergone major traumatic surgery within 6 months before screening, or who plan to undergo surgery during the study period; 6. Use of any drugs that inhibit or induce liver metabolism of drugs within 1 month before the test (eg: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRIs) Antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Volunteers who have taken any drugs (including vitamin products and Chinese herbal medicines) within 14 days before the test; 8. Volunteers have taken any clinical research drugs within 3 months before the trial and/or participated in medical device clinical investigators, or plan to participate in other clinical trials during this study; 9. Volunteers who donated blood or lost a lot of blood (=200 mL, excluding menstrual bleeding in women), received blood transfusion or used blood products within 3 months before the trial; 10. Those who smoked more than 5 cigarettes per day in the 3 months before the trial, or who did not agree to quit smoking during the trial; 11. Frequent drinkers within 6 months before the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or who do not agree to abstain from alcohol during the trial By; 12. Those with a history of drug abuse or drug abuse; 13. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, pulse 100 bpm), or physical examination, electrocardiogram, laboratory tests (blood routine, Urine routine, stool routine, blood biochemistry, coagulation function tests) were judged by the clinician as abnormal and clinically significant; 14. Volunteer hepatitis B virus surface antigen (HBsAg), hepatitis C antibody assay (HCV-AB), human immunodeficiency virus antigen and antibody primary screening test (HIVAg/Ab), syphilis toluidine red unheated serotonin test (TRUST ) test positive; 15. Pregnant and/or lactating women, or those with abnormal serum pregnancy test; 16. Difficulty in collecting venous blood or unable to tolerate venipuncture; 17. Volunteers who are lactose intolerant; 18. Have taken a special diet (including grapefruit, chocolate, xanthine-rich foods/drinks) within 48 hours before the first administration of the trial and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, Grapefruit juice, caffeinated beverages (more than 8 cups per day on average, 200 mL per cup); 19. Gene detection CYP2C9 gene X2/X3, X2/X2, X3/X3 belong to weak m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed