Postoperative pain
Conditions
Interventions
Group 3:Administration of the experimental drug "KLA578-1 for injection" 240mg
Group 2 (etoracoxib group):Administration of control drug "etocoxib tablet"
Multiple dose group:Administration of the experimental drug "KLA578-1 for injection" 120mg
Group 2 (KLA578-1 group for injection):Administration of the experimental drug "KLA578-1 for injection”
Group 1:Administration of the experimental drug "KLA578-1 for injection" 60mg
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; 2. Chinese subjects aged 18-45 years (including boundary values), both male and female; 3. The weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg; The BMI was in the range of 19.0 to 26.0 (including the critical value). Body mass index (BMI) = weight (kg)/height ^2 (m^2); 4. Patients with normal or abnormal results of physical examination, vital signs, 12-lead electrocardiogram, laboratory examination [blood routine, urine routine, blood biochemistry, coagulation function, blood transfusion, blood pregnancy (only for fertile women), stool routine, etc.] and other examination items have no clinical significance; 5. The subject (and his/her partner) has no fertility plan and the subject has no sperm/egg donation plan within 3 months from the signing of the information to the final administration of the experimental drug; And voluntarily take at least one non-drug contraceptive from the time of signing the information to the last PK blood collection (see Annex 1); And voluntary use of effective contraception within 3 months after the last dose of the investigational drug (see annex 1); 6. The subject is able to communicate well with the investigator and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Previous specific allergic diseases (asthma, urticaria, eczema, etc.), or allergies (such as allergy to two or more drugs, food or pollen, or known allergy to excipients and apis of this product); 2. Have a history of cardiovascular system (such as ischemic heart disease), endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of inherited immune deficiency), metabolic abnormalities, and other medical history, and researchers believe that the current clinical significance; 3. Patients with previous gastrointestinal ulcers (such as gastric ulcer, duodenal ulcer) or gastrointestinal bleeding; 4. Patients who have received surgery within 6 months before screening that researchers judge will affect drug absorption, distribution, metabolism, and excretion; Or had undergone surgical procedures within 4 weeks prior to administration; Or planned to undergo surgery from the date of screening to the last PK blood collection of the trial; 5. Have used any drug (including prescription drugs, over-the-counter drugs, Chinese herbs, dietary supplements/health products (such as vitamins), etc.) within 14 days prior to administration; 6. Those who have used inducers or inhibitors of major CYP450 enzymes (CYP3A, CYP2C9, CYP2D6, CYP1A2, and CYP2C19) within 30 days prior to administration (see Annex 2); 7. Patients who have used any investigational drug or clinical device within the 3 months prior to administration, or who plan to participate in other clinical trials during the study period; 8. Those who received the vaccine within 1 month before administration, or planned to receive the vaccine from the screening date to the last PK blood collection of the trial; 9. Drug abusers or drug dependents; 10. Patients with difficulty swallowing tablets (this exclusion criterion applies only to subjects enrolled in SAD study Group 2); 11. Patients who cannot tolerate venous puncture or have a history of fainting needles and fainting blood; 12. People who donate blood or lose a large amount of blood (> 200 mL) within 3 months before dosing, receive blood transfusions or use blood products, or plan to donate blood or blood components within 3 months from the date of screening to the last PK blood collection of the test; 13. The female subject is pregnant or breastfeeding; 14. Those who have had unprotected sex within 2 weeks prior to drug administration; 15. Those who have special requirements for diet and cannot comply with a unified diet; 16. Those who smoked more than 3 cigarettes per day on average in the 3 months prior to administration, or were unwilling to stop using any tobacco products from the screening date to the last PK blood collection period of the test; 17. Previous alcohol abuse (i.e., more than 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14 g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or regular alcohol consumption (more than 14 standard units per week) in the six months prior to administration; Or unwilling to stop drinking alcohol or any alcohol-based products from the date of screening until the last PK blood collection of the test; 18. Excessive consumption (more than 8 cups, 1 cup =250 mL) of tea, coffee and/or caffeinated beverages (such as milk tea, cola, etc.) per day prior to administration, or unwilling to stop drinking tea, coffee and/or caffeinated beverages from t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory examination;12-lead electrocardiogram;Vital sign;Physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed