Osteoarthritis, rheumatoid arthritis
Conditions
Interventions
Case:Meloxicam 15mg
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 45 years old male; 2. CYP2C9 * 3 alleles are homozygous mutant (C / C) subjects; 3. The male subject weighs >=50kg, and the body mass index (BMI) is in the range of 19.0 ~ 26.0 kg / m2 (body mass index = weight (kg) / height 2 (m2)), including the boundary value; 4. Subjects did not have a fertility plan, sperm donation or egg plan during the trial (including male subjects) and within 90 days after the trial, and volunteered to take effective physical contraceptive measures; 5. Know the nature, significance, possible benefits, inconvenience and potential risks of the trial in detail before the trial, be able to understand the procedures and methods of the research, be willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign informed consent book.
Exclusion criteria
Exclusion criteria: 1. Patients with specific allergic diseases (asthma, urticaria, eczema, etc.) or allergies (such as allergies to two or more drugs, food or pollen, or known excipients and drug substances (US) Roxicam) or other non-steroidal anti-inflammatory drugs (NSAID) allergies); 2. People with previous serious diseases, including but not limited to circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities; 3. People with previous gastrointestinal ulcer (such as gastric ulcer, duodenal ulcer) or gastrointestinal bleeding; 4. Those who have undergone major trauma surgery within 6 months before screening or plan to undergo surgery during the study period; 5. Any drug that inhibits or induces liver metabolism (eg: inducerbarbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole); inhibitorSSRI within 1 month before the test Antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Subjects who took any drugs (including vitamin products and Chinese herbal medicines) within 14 days before the trial; 7. Subjects donated blood or lost a lot of blood (>=200mL) within 3 months before the test, who received blood transfusion or used blood products; 8. Those who smoked more than 5 cigarettes in the 3 months before the trial, or those who did not agree to smoke during the trial period; 9. Those who regularly drink in the 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), or do not agree to ban alcohol during the test By; 10. People with a history of drug abuse or drug use; 11. People with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, heart rate 100 bpm), or physical examination, ECG, laboratory examination (blood routine, Urine routine, stool routine, blood biochemistry, blood coagulation function test) were judged by clinicians as abnormally clinically significant; 12. Subjects who tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and syphilis snail specific antibody (RPR); 13. Difficulties in venous blood collection or intolerance of venipuncture; 14. Have taken a special diet (including grapefruit, chocolate, xanthine-rich foods / beverages) within 48 hours before the first dose of the trial and / or overdose tea, coffee, grapefruit / grapefruit juice every day for the past 3 months, Grapefruit juice, caffeinated beverages (average over 8 cups per day, 200 mL per cup); 15. Alcohol breath test> 0.0 mg / mL; 16. Positive drug abuse screening; Subjects could not complete the study due to personal reasons or the investigators believed that the subjects had any other factors that were not suitable for participation in the trial (such as inability to understand the research requirements, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Meloxicam; | — |
Countries
China
Contacts
Public ContactGuo-Ping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed