non-cancerous pain
Conditions
Interventions
Upper arm group:Sufentanil transdermal patches are used
Chest group:Sufentanil transdermal patches are used
Abdomen group:Sufentanil transdermal patches are used
Back group:Sufentanil transdermal patches are used
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male or female volunteers aged 18-45 years (including 18 and 45 years) with a history of non cancerous pain (regardless of the cause); 2. Male volunteers should weigh no less than 50 kg, and female volunteers should weigh no less than 45 kg. Body mass index (BMI) [=weight kg/(height m)^ 2] is within the range of 19-26 kg/m^2 (including 19 and 26); 3. The Numerical Rating Scale (NRS) score within 24 hours prior to enrollment is <=4; 4. Pain symptoms were stable within 14 days prior to enrollment, and based on medical history, it is predicted that pain symptoms will remain relatively stable throughout the entire study period; 5. Female volunteers have taken effective contraceptive measures within 14 days before screening and all volunteers are willing to have no pregnancy plans during the trial and voluntarily take effective contraceptive measures within 6 months after the trial ends; 6. Capable of reading, understanding, and voluntarily signing informed consent forms (ICFs), and able to complete research according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with abnormal vital signs (systolic blood pressure140 mmHg, diastolic blood pressure90 mmHg); Heart rate100 bpm) or abnormalities in physical examination, electrocardiogram, and laboratory tests with clinical significance (for screening period heart rate = 60 beats/min or systolic blood pressure <= 90 mmHg, the judgment of the clinical research doctor shall prevail); 2. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive; 3. Individuals who have previously or currently suffered from circulatory system, endocrine system, nervous system (dizziness syndrome, post-stroke sequelae, including but not limited to respiratory rhythm abnormalities, hemiplegia, aphasia, limb sensory abnormalities; other central nervous system diseases such as intracranial tumors, traumatic brain injury, intracranial hypertension caused by any reason that may affect the respiratory center), digestive system (nausea, vomiting, gastrointestinal obstruction, paralytic intestinal obstruction, etc.), respiratory system (ventilation dysfunction, SpO2 <= 95%, bronchial asthma, chronic obstructive pulmonary disease, obstructive sleep apnea hypopnea syndrome), urogenital system, hematology, immunology, psychiatry, metabolic abnormalities, or any other clinically serious diseases that can interfere with test results; 4. Individuals with a specific history of allergies (asthma, urticaria, eczema, etc.), or an allergic constitution (such as allergies to two or more drugs, foods such as milk or pollen), or known allergies to opioids such as sufentanil or naltrexone, or allergies to adhesives (pressure-sensitive adhesives, vitamin E) in similar patches; 5. Individuals with a history of frequent nausea or vomiting caused by any underlying cause; 6. Skin abnormalities and/or skin diseases at the site of administration, including but not limited to: unhealed skin injuries, dermatitis, burns, tattoos, scars, etc; 7. Those who have used any medication or health supplements (including Chinese herbal medicine) within 14 days before administration; 8. Those who have used, are currently using, or need to use the following drugs within 7 days before administration: CYP3A4 inhibitors such as erythromycin, ketoconazole, and itraconazole; Calcium ion antagonists such as verapamil and diltiazem; Chemicals, traditional Chinese medicine and traditional Chinese patent medicines and simple preparations that may inhibit CYP3A4; CYP3A4 inducers: such as rifampicin, phenytoin sodium, carbamazepine; Chemicals, traditional Chinese medicine, traditional Chinese patent medicines and simple preparations that may induce CYP3A4; - Drugs that have inhibitory effects on the central nervous system, such as barbiturates, sedatives, tranquilizers, alcohol, and other anesthetics; - anticholinergic drugs, diuretics, muscle relaxants; 9. Individuals who have consumed special foods (such as grapefruit and grapefruit containing products, chocolate, any caffeinated or xanthine rich foods (such as animal liver) or engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 48 hours prior to administration; 10. Individuals who have consumed any alcoholic products or tested positive for alcohol within 48 hours prior to administration; 11. Individuals who have tested positive for drug abuse screening or have used soft drugs (such as marijuan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram;Administration site/peripheral evaluation;Adhesion evaluation;Blood pressure; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed