acute pain
Conditions
Interventions
10µg/kg dose group:There are 8 cases in the experimental group and 2 cases in the placebo group, and each trial participant will receive only one dose of the drug.
15µg/kg dose group:There are 8 cases in the experimental group and 2 cases in the placebo group, and each trial participant will receive only one dose of the drug.
5µg/kg dose group:There are 8 cases in the experimental group and 2 cases in the placebo group, and each trial participant will receive only one dose of the drug.
2µg/kg dose group:There are 8 cases in the experimental group and 2 cases in the placebo group, and each trial participant will receive only one dose of the drug.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Participants in the trial signed an informed consent form before the trial, and fully understood the content, process of the trial and possible adverse reactions; they voluntarily participated and were able to complete the study in accordance with the requirements of the trial protocol; 2.Male or female trial participants aged 18 to 55 years old (including 18 and 55 years old); 3.Male weight not less than 50.0 kg, female weight not less than 45.0 kg, and body mass index (BMI) within the range of 18.5~28.0 kg/m^2 (including critical values); 4.The trial participants and their partners are willing to have no plans for childbearing from 2 weeks before the self-screening to 6 months after the last administration of the investigational drug, and voluntarily take effective contraceptive measures, with no plans for sperm or egg donation.
Exclusion criteria
Exclusion criteria: 1.Those who are allergic or have contraindications to opioids and other drugs that may be used in clinical trials, or have an allergic constitution (such as those allergic to two or more drugs or foods); 2.Those with diseases that occurred or are occurring before screening and have abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system, blood and lymphatic system, urinary system, endocrine system, and immune system; 3.Those with a history of heart-related diseases such as familial hereditary heart disease, ischemic heart disease, heart failure, and malignant arrhythmia; those with a history of QTc prolongation; or those with the following electrocardiogram (ECG) findings during the screening period: (1) QTcF > 450ms, (2) second-degree or third-degree atrioventricular block, (3) bundle branch block, (4) PR interval >=20ms; or those with ECG results judged by the researcher to be abnormally clinically significant during the screening period; 4.Participants who, during the screening period, have clinically significant abnormal test results as judged by the researcher and are deemed unsuitable to participate by the researcher, including those from physical examinations, vital signs, laboratory tests, etc.; 5.Those who are positive for hepatitis B surface antigen, or hepatitis C virus antibody, or treponema pallidum antibody, or human immunodeficiency virus antibody during screening; 6.Screen out those who have undergone major surgery within the previous 3 months or plan to undergo surgery during the study period; 7.Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, vitamins, and health supplements before randomization, and the interval between such drugs and the randomization of trial participants is less than 14 days or 5 times the half-life of the drug/active metabolite (whichever is longer); those who have used any drugs that inhibit or induce hepatic metabolism of drugs within 30 days before randomization (such as: inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, statins); 8.Those who, in the first 3 months, drank excessive amounts of tea, coffee, and/or caffeinated beverages on average every day (more than 8 cups on average, 1 cup ˜ 250mL), or those who cannot stop drinking during the trial period; 9.Exclude those who have an average weekly alcohol consumption of more than 14 units in the previous 3 months (1 unit of alcohol is approximately 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or those who cannot abstain from alcohol during the trial period; 10.Those who have eaten or drunk pitaya, mango, pomelo, carambola, or food or beverages prepared from them, or food or beverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that affect the absorption, distribution, metabolism, or excretion of drugs within the random first 48 hours; or those who cannot stop consuming the above-mentioned diets during the trial period; 11.Those who have special dietary requirements and cannot accept the unified diet; 12.Screen those who smoke more than 5 cigarettes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE) / Serious Adverse Event (SAE);Pharmacokinetic parameters RFUS-188AUCoe AUCo-e. Cmax, Tmax A2s tiazs MRT, CL2s V2, etc.; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed