Analgesia
Conditions
Interventions
test group:0.75 mg, 1.5 mg and 3.0 mg, intravenous pump injection for 2 minutes
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign written informed consent and be able to comply with research procedures and requirements; 2. The age range is 18 to 60 years old, and there is no limit to men and women; 3. Patients with chronic non-cancer pain (such as frozen shoulder, chronic low back pain, and myofascial pain syndrome patients); 4. The body mass index (BMI) is between 19.0 and 30.0 kg/m2 (including 19 and 30); 5. The systolic blood pressure is 90-140 mmHg, the diastolic blood pressure is 50-90 mmHg, the heart rate is 50-100 beats/min, and the blood oxygen saturation under indoor conditions is> 95%; 6. Willing and able to quit drinking and smoking during the study period and not taking drugs other than the experimental drugs.
Exclusion criteria
Exclusion criteria: 1. The medical history and/or physical examination results show that the subject has a clinically significant disease (except for the indications in this study); 2. Vital signs or clinical laboratory test results are abnormal and have clinical significance. The researcher can decide to repeat the test for abnormal vital signs and/or laboratory tests. If the repeated test is within the normal reference value range, only if the researcher believes that the previous findings will not introduce other risk factors and will not interfere with safety The subject can only be included in the interpretation of the data; 3. The gastrointestinal tract, kidneys, cardiovascular, liver, metabolism, allergies, skin diseases, blood, lungs, nerves that have had or have had activity recently (within 35 days before screening) and have clinical significance as judged by the researcher System, or mental illness or disorder; 4. In patients with chronic non-cancer pain, there are situations that affect the evaluation of research results; 5. Those who have used non-steroidal anti-inflammatory drugs within one week before check-in; 6. Suffering from peripheral vascular and rheumatic immune diseases; 7. Clinically significant ECG abnormalities were found during screening, including QTcF >= 450 milliseconds (male) or >= 470 milliseconds (female); 8. Use of any tobacco or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges or nicotine gum) within 6 months before screening; 9. Any prescription drugs or illegal drugs used within 35 days before screening and throughout the study period. Take any over-the-counter medications 72 hours before day 1 and throughout the study period. Take the test drug within 35 days or 5 half-lives (whichever is longer) before screening; 10. Take alcohol within 72 hours before check-in; 11. There is a history of drug, drug or alcohol abuse within 1 year before screening [more than 14 standard units of alcohol consumed per week (1 unit = 360 mL beer or 45 mL 40% alcoholic spirits or 150 mL wine)]; 12. There have been clinically significant adverse reactions related to the administration of opioid analgesics or naloxone; 13. The result of urine drug screening, urine cotinine test or alcohol breath test is positive; 14. Those who are non-negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), and syphilis serum reaction (TRUST); 15. Donate blood or plasma to blood banks or for clinical research (except for research screening) within 35 days before screening; 16. Receive blood products within 6 months before screening; 17. Those who have received live/attenuated vaccination within 4 weeks before screening or plan to receive live/attenuated vaccination during the trial period; 18. The HCG value of the blood pregnancy test during the screening period or the baseline period is higher than the reference value for non-pregnancy; 19. Male and female subjects who are unwilling to abstain from sex and use effective physical contraceptive measures such as condoms and intrauterine devices during the study period and within 90 days after the last medication; 20. Any other diseases or reasons for which the researcher believes that the subject is not suitable for clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed