Chronic pain that cannot be controlled by non-opioid painkillers
Conditions
Interventions
Group TR:The patients were randomly assigned to group TR in a 1:1 ratio. After an overnight fast of at least 10h, subjects applied 1 patch (20mg) of the corresponding test preparation or reference pre
Group RT:Randomization was performed in a 1:1 ratio to the RT group. After an overnight fast of at least 10h, subjects applied 1 patch (20mg) of the corresponding test preparation or reference prepara
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male and female subjects aged 18 to 65 years old (including 18 and 65 years old), with an appropriate gender ratio; 2. The weight of male subjects should be no less than 50.0kg, and that of female subjects no less than 45.0kg. The body mass index (BMI) is within the range of 19.0 to 26.0kg/m ² (including the critical value). 3. For fertile female subjects, from 2 weeks before screening to 90 days after the last administration, and for male subjects (whose partners are fertile women), from signing the informed consent form to 90 days after the last administration, they have no plans for having children and take appropriate contraceptive measures (contraceptive measures are provided in Appendix 4: Contraceptive Measures and Contraceptive Requirements), and avoid donating eggs/sperm. 4. Subjects who can understand and are willing to abide by the clinical trial protocol to complete this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are known to have a history of allergy to the test drug (including the concomitant drug naltrexone hydrochloride tablets) or other opioid drugs, or are allergic to other foods, drugs, etc. 2. Those with a history of severe diseases in the respiratory system (such as chronic obstructive pulmonary disease, asthma and sleep apnea syndrome), cardiovascular system, digestive system, urinary system, endocrine system, nervous system, hematology, immunology, psychiatry, or currently suffering from diseases in the above systems and determined by the researcher as unsuitable for inclusion in the group; 3. People with sensitive skin (such as those who have been allergic to cosmetics or sunlight before); 4. A history of skin diseases such as atopic dermatitis, psoriasis, vitiligo, or diseases with known changes in skin appearance or physiological reactions (such as diabetes, porphyria); 5. There are open wounds on the outer side of the upper arm, or there is redness, irritation or damage, or the skin color between the two arms is significantly different, or there are conditions that affect drug adhesion, skin evaluation, and drug absorption (such as excessive hair, scar tissue, tattoos, abnormal skin color, etc.); 6. Those who frequently experience nausea and vomiting without obvious causes in the past; 7. Those with a history or symptoms of orthostatic hypotension, or those whose systolic blood pressure (SBP) decreased by >=20mmHg or diastolic blood pressure (DBP) decreased by >=10mmHg within 3 minutes after changing from the supine position to the upright position during the screening visit; 8. Those with a history of long QT syndrome or a family history of long QT syndrome, or those whose 12-lead electrocardiogram (ECG) results during the screening period were judged by the investigator to be clinically significant and were not suitable for inclusion, or those with a QTcF interval of >450ms in men and >470ms in women (calculated using Fridericia's formula: QTcF = QT/(RR ^ 0.33)); 9. The results of vital signs, physical examination, and laboratory tests (blood routine, urine routine, blood biochemistry, and coagulation function) are abnormal and clinically significant as determined by the researcher and the patient is not suitable for enrollment. 10. Those who have used monoamine oxidase inhibitors or liver drug enzyme inhibitors or inducers (such as ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin, verapamil, fluvoxamine, carbamazepine, phenytoin, phenobarbital, chloramphenicol, isoniazid, etc.) within 30 days prior to screening; 11. Those who have special dietary requirements and cannot accept a uniform diet; 12. Those who cannot tolerate venipuncture or have a history of fainting at the sight of needles and blood; 13. Those who frequently consumed alcohol within the six months prior to screening, that is, those who consumed an average of more than 14 units of alcohol per week (1 unit ˜360ml of beer or 45ml of 40% alcohol spirits or 150ml of wine), and those who could not stop using any alcoholic products during the trial period, or those whose breath alcohol test results were greater than 0mg/100ml; 14. Those who smoked more than five cigarettes per day for three months prior to screening, or were unable to stop using any tobacco products during the trial period; 15. Those who have participated in any clinical trial and received the trial drug within the three months prior to screening, or those who plan to part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCo-t;Cmax;AUCo-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Index;Adhesion Assessing;AUC_%6Extrap;t1/2;Tmax;?z; | — |
Countries
China
Contacts
Public ContactZhihong Xie
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed