µ/?/d receptor mixed agonist, analgesic
Conditions
Interventions
Pre-test group 1:All received YR-1702 injection. According to the PK results of the 0.1 mg group, the dose design and PK blood sampling time point of the subsequent dose group may be adjusted.
Test group 2:To conduct a comparative study on the pharmacokinetics of YR-1702 injection and YR-1702 injection simulant 0.3mg
Test group 3:To conduct a comparative study on the pharmacokinetics of YR-1702 injection and YR-1702 injection simulant 0.6mg
Test group 4:To conduct a comparative study on the pharmacokinetics of YR-1702 injection 0.2mg and YR-1702 injection simulant 1mg
Test group 5:To conduct a comparative study on the pharmacokinetics of YR-1702 injection and YR-1702 injection simulant 1.5mg
Test group 6:To conduct a comparative study on the pharmacokinetics of YR-1702 injection and YR-1702 injection simulant 2mg
Test group 7:To conduct a comparative study on the pharmacokinetics of YR-1702 injection and YR-1702 injection simulant 2.5mg
Test group 8:To conduct a comparative study on the pharmacokinetics of YR-1702 injection and YR-1702 injection simulant 3mg
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 50 years(including 18 and 50 years old), half male and half; 2. The weight of male subjects is not less than 50kg, and the weight of female subjects is not less than 45kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI is in the range of 19.0~26.0kg/m2 (including the critical value); 3. Subjects (including partners) have no sperm donation, egg donation plan, no pregnancy plan and voluntarily take effective contraceptive measures within 6 months after signing the informed consent form to the last administration of the investigational drug. For specific contraceptive measures, see Appendix 2 ; 4. Voluntarily sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions.
Exclusion criteria
Exclusion criteria: 1. Medical history of cardiovascular, respiratory system (such as sleep apnea syndrome), liver, kidney, nervous system, blood system or mental disorders deemed clinically significant by the investigator; 2. Difficulty in venous blood collection, or a known history of needle fainting and bleeding; 3. Those who have undergone major surgery or severe trauma within 6 months before screening or plan to undergo surgery during the study period; 4. Those who are known to be allergic to two or more foods and drugs; 5. Those who are known to be allergic to opioids, or those who have contraindications to the use of such drugs; 6. Female subjects are breastfeeding during the screening period or during the trial, or the abnormal blood pregnancy test results are clinically significant; 7. Abnormal electrocardiogram results at screening have clinical significance, such as QTcF 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 beats/min) or abnormal physical examination and laboratory tests have clinical significance (subject to the judgment of the clinician); 9. Blood oxygen saturation is less than 95% during screening; 10. Those with any history of drug abuse or positive urine drug test during the screening period within 1 year before screening; 11. Frequent drinkers within 6 months before screening (drinking more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine) or alcohol breath test results on the day before the first dose >0mg/100mL; 12. Those who have donated blood or lost a large amount of blood (>400mL, excluding women's menstrual blood loss), received blood transfusion or used blood products within 3 months before screening; 13. Those who smoked >=5 cigarettes per day within 3 months before screening or who could not stop using any tobacco products during the trial; 14. Those who participated in any clinical trial and took any clinical trial drug within 3 months before screening; 15. Those who have received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening, or plan to receive inactivated/live/attenuated vaccine during the trial; 16. Fit and take any drugs that alter liver enzyme activities CYP2C9, CYP2C19, CYP3A4, and CYP2D6 28 days before screening or during the study period, including strong inhibitors and inducers that affect liver metabolic enzymes (see Appendix 3 for specific drug information); 17. Received other prescription or over-the-counter drugs that the investigator considers affecting the evaluation results of this study within 14 days before the first use of the test drug; 18. Those who ingested grapefruit or grapefruit juice within 7 days before the first use of the test drug, or did not agree to avoid taking any beverage or food containing grapefruit every day during the test; 19. Those who have taken any alcohol-containing products within 48 hours before using the test drug for the first time, or who do not agree to avoid taking any alcohol-containing products every day during the test; 20. Take any caffeine-rich food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first use of the test drug, or do not agree to avoid taking any caffeine-rich food or drink ev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Urine concentration;Fecal drug concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed