analgesia
Conditions
Interventions
experimental group:Meloxicam injection
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 ~ 45 years, including the boundary value; 2) Female subjects weighing >= 45kg, male subjects weighing >= 50kg, body mass index (BMI) in the range of 19.0 ~ 26.0 kg / m2 (body mass index = body weight (kg) / height 2 (m2)), including boundaries value; 3) Subjects (including male subjects) during the trial and within 90 days after the end of the trial have no birth plan, donated sperm or egg plan and voluntarily take effective physical contraception. Before the trial, understand the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign an informed consent.
Exclusion criteria
Exclusion criteria: 1) People 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 (US Loxicam) or other non-steroidal anti-inflammatory drugs (NSAID) allergies); 2) Those who have suffered from the following 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 suffered from peptic 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 perform surgery during the study period; 5) Have used any drug that inhibits or induces liver metabolism of the drug within 1 month before the test (eg: inducer-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor-SSRI Antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Those who took any medicine (including vitamin products and Chinese herbal medicine) within 14 days before the test; 7) Participants who took any clinical research drugs / or participated in clinical research of medical devices within 3 months before the trial, or plan to participate in other clinical trials during this study; 8) Subjects who donated blood or lost a lot of blood ( >= 200mL) within 3 months before the test, received blood transfusion or used blood products; 9) Those who smoked more than 5 cigarettes per day in the 3 months before the trial, or who did not agree to ban smoking during the trial; 10) Frequent drinkers within 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% alcohol or 150 mL of wine), or disagree with the prohibition of alcohol during the test By; 11) Those who have a history of drug abuse or drug use; 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 radiography examination are clinically determined by the clinician as abnormal; 13) Subjects who tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis-specific antibody; 14) Women who are pregnant and / or lactating, or who have a positive serum pregnancy test; 15) Those who have difficulty collecting venous blood or cannot tolerate venipuncture; 16) Take special diets (including grapefruit, chocolate, foods / drinks rich in xanthine) within 48 hours before the first dose of the trial and / or drink excessive amounts of tea, coffee, grapefruit / grapefruit juice, Grapefruit juice, caffeinated beverages (average more than 8 cups per day, 200 mL per cup); 17) Alcohol breath test> 0.0 mg / mL; 18) Those who are positive for drug abuse screening; The subject could not complete the study due to personal reasons or the investigator believes that the subject has any other factors that are not suitable for participating in the trial (such as inability to understand the study requirements, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meloxicam blood concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed