None listed
Conditions
Interventions
A1:Use a syringe with a needle size of 0.6 × 32TWLB to inject 2 mL of sterile water for injection into the hip i.m. once a day for 7 consecutive days.
A2:Use a syringe with a needle size of 0.6 × 25TWLB to inject 2 mL of sterile water for injection into the hip i.m. once a day for 7 consecutive days.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers; 2. Age: 18-45; 3. Weight >= 50kg, 19 <= BMI <= 26 (BMI=weight (kg) /height 2 (m^2)); 4. The comprehensive physical examination is qualified, that is, there is no abnormality or no clinical significance in vital signs, physical examination, routine blood and urine test, blood sugar, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, ECG, smoke test, urine drug screening, alcohol breath test, chest X-ray test, etc.; 5. Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial before the study, and voluntarily participate in this clinical trial, be able to communicate well with investigators, comply with the requirements of the entire study, and have Ability to understand and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. (Interview) Those who have participated in any other clinical trial within three months before the trial; 2. (Interview) Any disease that may affect the safety of the test or the internal process of the drug, including but not limited to: heart, liver, kidney, endocrine, digestive tract People with previous or existing diseases of the immune system and respiratory system [especially those with cardiovascular diseases, including those at risk of cardiovascular diseases, any gastrointestinal diseases that affect drug absorption (such as irritable bowel syndrome symptoms, inflammatory bowel disease history), active pathological bleeding (such as peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczema dermatitis, asthma, etc.]; 3. (Interview) Allergic constitution: if there is a history of drug, food allergy or skin allergy; 4. (Interview) Have used any drugs that inhibit or induce liver metabolism of drugs within 28 days before using the study drug (common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, amlumide, griseofulvin, trimethylcarbamate, phenytoin, glumet, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides, etc.); 5. Those who have used any medicine (including Chinese herbal medicine) and health care products within 14 days before the first administration; 6. (Interview) Those who have special requirements for food and cannot follow the unified diet (such as intolerance to standard meals); 7. (Interview) Those who can not tolerate intravenous puncture, intramuscular injection and /or have a history of blood sickness and needle sickness; 8. (Interview) Those who have drunk too much tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup=250mL) for a long time in the past; Or study the special diet that affects the absorption, distribution, metabolism and excretion of drugs by taking any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first administration; 9. (Interview) Previous alcoholism (that is, men drink more than 28 standard units every week and women drink more than 21 standard units every week (1 standard unit contains 14g of alcohol, such as 360mL beer or 45mL spirits of 40% alcohol or 150mL wine); Or frequently drank alcohol (more than 14 standard units per week) within 6 months before the trial; Or those who have taken any alcoholic products within 24 hours before the first administration; 10. (Interview) Those who have donated blood or massive bleeding (more than 450mL) within 3 months before the first administration of the study, or who plan to donate blood or blood components during the study or within 3 months after the end of the study; 11. (Interview) Acute disease occurs in the screening stage before the study or before the study medication; 12. (Interview) Those who have taken foods or beverages containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, mango, pitaya, grape juice, orange juice, etc., which contain rich flavonoids or citrus glycosides) within 24 hours before the first administration; 13. (Interview) Those who have undergone surgery within three months prior to the screening period, or who plan to undergo surgery during the study period; 14. (Interview) Have a history of drug abuse; History of drug abuse; 15. (Interview) Those who smoke more than 5 cigare
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Both groups asked the subjects about their feelings (such as tingling, distension, pain, etc.) at the time of injection, drug pushing and after injection and recorded them.;Creatine Kinase; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed