Osteoarthritis, rheumatoid arthritis
Conditions
Interventions
A:TR group: phase I: Meloxicam Suspension Injection (T) 7.5 mg, phase II: Mobi (R) 7.5 mg
RT group: phase I: R, phase II: T.
B:Meloxicam Suspension Injection 15 mg
C:Meloxicam Suspension Injection 30 mg
D:Meloxicam Suspension Injection 60 mg
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 45 years, including the boundary value; 2. Female subjects weigh >= 45kg, male subjects weigh >= 50kg, body mass index (BMI) in the range of 19.0 ~ 26.0 kg / m2 (body mass index = weight (kg) / height 2 (m2)), including borders value; 3. Subjects had no birth planning, donated sperm or egg plan and volunteered to take effective physical contraception during the trial (including male subjects) and within 90 days after the end of the trial. 4. Know the nature, significance, possible benefits, possible inconvenience and potential risks of the test before the test, understand the procedures and methods of the study, and be willing to strictly follow the clinical trial plan to complete the test and voluntarily sign the informed consent.
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 APIs for this product) Loxikang 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. Those who have had previous peptic ulcers (such as gastric ulcer, duodenal ulcer) or gastrointestinal bleeding; 4. Surgery with major trauma within the first 6 months of screening, or who plan to undergo surgery during the study period; 5. Any drug that inhibits or induces liver metabolism of the drug within one month prior to the test (eg, inducer-barbital, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor-SSRI) Antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; 6. Subjects who took any drug (including vitamin products and Chinese herbal medicines) within 14 days before the test; 7. Subjects who have taken any clinical study drug within 3 months prior to the trial/or participated in a clinical study of a medical device, or who plan to participate in other clinical trials during the study period; 8. Subjects donate blood or massive blood loss (>=200mL) within 3 months before the test, receive blood transfusion or use blood products; 9. More than 5 cigarettes per day for the first 3 months of the trial, or those who do not agree to smoke during the trial period; 10. Those who regularly drink alcohol within 6 months before the test, that is, drink 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 disagree with alcohol during the test period. By; 11. Those who have a history of drug abuse or a history of drug abuse; 12. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, heart rate 100 bpm), or physical examination, electrocardiogram, laboratory examination (blood routine, Urine routine, stool routine, blood biochemistry, coagulation function test), abdominal B-ultrasound examination, chest X-ray examination by the clinician as abnormal and clinically significant; 13. Subjects with hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and syphilis specific antibody (RPR) test positive; 14. Pregnant and/or lactating women, or those who have a positive pregnancy test; 15. Patients with venous blood collection or inability to tolerate venipuncture; 16. Take a special diet (including grapefruit, chocolate, jaundice food/drink) within 48 hours prior to the first dose and/or drink excessive tea, coffee, grapefruit/grapefruit juice every day for the last 3 months. Grapefruit juice, caffeinated beverages (average of 8 cups per day, 200 ml per cup); 17. Alcohol breath test >0.0 mg/mL; 18. Drug abuse screening positive; 19. The subject is unable to complete the study for personal reasons or the investigator believes that the subject has any other factors that are not suitable for participation in the trial (eg, inability to understand research requirements, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Meloxicam; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed