pain
Conditions
Interventions
15 mg, single dose, crossover:Sixteen subjects took orally 15mg of meloxicam Tablets or 15mg of meloxicam Injection intravenously in upper limbs on an empty stomach respectively, and used another prep
30 mg, single/multiple administration:It is planned to enroll 12 subjects to receive intravenous injection of 30 mg of meloxicam injection on an empty stomach in the morning of the first day, and 30 m
60 mg, single dose:It is planned to enroll 12 subjects to receive intravenous injection of 60 mg meloxicam injection.
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Participants must meet all the following criteria in order to be selected. 1) Chinese healthy subjects aged between 18 and 45 years (including threshold); 2) The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; The body mass index is within the range of 19-26 kg/m2 (including the boundary value). Body Mass Index (BMI)=Weight (kg)/Height 2 (m2); 3) The subjects (including male subjects) did not have a fertility plan, plan to donate sperm or eggs, and voluntarily adopted effective physical contraception measures 30 days before, during, and after the experiment; 4) Before the experiment, sign an informed consent form and have a thorough understanding of the experiment content, process, and potential adverse reactions. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded. 1) Individuals with specific allergic diseases (asthma, urticaria, eczema, etc.) or allergic constitution (such as allergies to two or more drugs, food, or pollen, or known allergies to excipients and raw materials of this product); 2) Individuals who have previously suffered from the following serious diseases, including but not limited to related diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities; 3) Individuals who have previously suffered from gastrointestinal ulcers (such as gastric or duodenal ulcers) or gastrointestinal bleeding; 4) Those who have received the vaccine within 2 weeks before the experiment or plan to receive the vaccine during the experiment; 5) Those who have undergone major trauma surgery within the first 6 months of screening, or plan to undergo surgery during the study period; 6) Those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotic, verapamil, fluoroquinolones, antihistamines) within one month before the test; 7) Subjects who have taken any medication (including vitamin products and Chinese herbal medicine) within 14 days before the experiment; 8) Subjects who have taken any clinical research drugs/participated in clinical research on medical devices within 3 months prior to the trial, or plan to participate in other clinical trials during this study period; 9) Subjects who donate blood or experience significant blood loss (= 200 mL, excluding female menstrual bleeding) within 3 months prior to the trial, and who receive blood transfusions or use blood products; 10) Those who smoke more than 5 cigarettes per day for the first 3 months of the experiment, or those who do not agree to ban smoking during the experiment period; 11) Regular drinkers within the first 6 months of the experiment, i.e. those who 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 those who do not agree to abstain from alcohol during the experiment; 12) Individuals with a history of drug abuse or drug use; 13) Those with abnormal vital signs (systolic pressure140 mmHg, diastolic pressure90 mmHg, heart rate100 bpm) or physical examination, electrocardiogram, laboratory tests (blood routine test, urine routine test, blood biochemical test, blood coagulation function test) judged by clinicians as abnormal and of clinical significance; 14) Subjects with positive results of hepatitis B B virus surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antigen antibody preliminary screening test (HIVAg/Ab), and treponema pallidum antibody (TP Ab); 15) Pregnant and/or lactating women, or those with abnormal serum pregnancy tests; 16) Difficulty in venous blood collection or inability to tolerate venous puncture or swallowing difficulties; 17) Within 48 hours before the first administration of the trial, the drug was taken
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tmax;Cmax;AUC0-last;Css, min;Css, max; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2;CL;Accumulation index of AUC; | — |
Countries
China
Contacts
Public ContactYang Guoping
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed