Postoperative pain
Conditions
Interventions
6 groups:Subcutaneous injection
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Those who fully understand the purpose and requirements of the test, voluntarily participate in the test and sign the informed consent approved by the ETHICS Committee; 2. Chinese adult males and females between the ages of 18 and 50 (including 18 and 50), both male and female; 3. Body mass index (BMI) between 19.0 and 26.0 kg/m2 (including critical value); BMI= weight (kg)/height 2 (m2).
Exclusion criteria
Exclusion criteria: 1. Persons who are allergic to the test drug or any component of the test drug or similar drugs, or who have allergic constitution; 2. Vital signs examination, physical examination, clinical laboratory examination (blood routine test, urine routine test, blood biochemical test, serological test, etc.), 12-lead electrocardiogram, and the results are abnormal and clinically significant as judged by the researcher; 3. Patients who have a history of chronic or serious diseases such as liver, kidney, respiratory, blood or lymph, endocrine, immune (including HIV positive or other immune deficiency diseases), mental or gastrointestinal system, or any surgery or disease that may affect drug absorption, distribution, metabolism or excretion; 4. Those who have been assessed to be at risk of potentially difficult airway; Patients with past or current respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome; 5. Patients with past or current cardiovascular and cerebrovascular diseases such as postural hypotension, arrhythmia, hypertension and epilepsy; 6. Persons with long QT syndrome or family history (grandparents, parents and siblings), or QTc interval > 450 ms; Indoor or left and right bundle branch block and/or QRS > 120ms; Ventricular ectopic beats were frequent (=1 premature ventricular beats occurred in ECG every 10s during screening period); Or abnormal resting heart rate (> 100 BPM); 7. Patients with history of anesthesia accidents; 8. Porphyria; 9. Patients who cannot tolerate venipuncture blood collection; 10. Scar constitution; 11. History of malnutrition or hypovolemic shock; 12. Those who have used any prescription drugs, non-prescription drugs, health care products, Chinese herbal medicine or Proprietary Chinese medicine within 2 weeks prior to screening; 13. Frequent use of sedatives, sleeping pills or other addictive drugs or positive results of drug abuse screening; 14. Those (including men) who had fertility, sperm donation, egg donation plans or did not agree to use effective non-drug contraceptive methods during the study period and for 3 months after the study period; 15. Women of childbearing age whose blood pregnancy test results are higher than the normal range or those in lactation; 16. Participants who have consumed excessive amounts of tea, coffee and/or caffeinated beverages in the past for a long time (more than 8 cups per day, 1 cup =250mL), or cannot give up drinking tea, coffee and other beverages during the study period; 17. Smoked more than 5 cigarettes a day in the last 3 months or could not give up smoking throughout the study period; 18. History of alcohol abuse in the 12 months prior to screening (i.e., more than 28 standard units per week for men and 21 standard units per week for women; 1 unit is equivalent to 285mL of beer, 25mL of spirits, or 150mL of wine), or those who drank regularly (more than 14 standard units per week) in the 6 months prior to screening, or who tested positive for alcohol breath, or who could not give up drinking throughout the study period; 19. Those who had donated blood or lost blood =400mL within 3 months prior to screening, or who planned to donate blood during the study period and within 3 months after the study; 20. Have participated in clinical trials of other drugs within 3 months prior to screening, or plan to participate in clinical trials of other drugs during the study period; 21. Those who are expecte
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of a single subcutaneous dose of long-acting ropivacaine injection in healthy subjects;Pharmacokinetics of a single subcutaneous administration of long-acting ropivacaine injection in healthy subjects;Optimal single point subcutaneous dose for long-acting ropivacaine injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of a single subcutaneous administration of long-acting ropivacaine injection in healthy subjects; | — |
Countries
China
Contacts
Public ContactWang Meixia
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed