noncancerous pain
Conditions
Interventions
Pre-test group 1:In group A, 2 volunteers applied sufentanil transdermal patch (0.36 mg/2.5 cm2/ patch) for 72 h, and in group B, 2 volunteers continued to receive Sufentanil citrate injection (2.5 µg
Test group 2:Twelve volunteers in group A were treated with sufentanil transdermal patch (0.36 mg/2.5 cm2/ patch) for 72 h, and eight volunteers in group B were treated with sufentanil citrate injecti
Test group 3:Cross apply sufentanil transdermal patch (0.72 mg/5 cm2/ patch) or fentanyl transdermal patch (25 µg/ hour, 4.2 mg/ patch) for 72 h.
Test group 4:Single application of Sufentanil transdermal patch for 72 h (1.44 mg/10 cm2/ patch) in 12 volunteers
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male or female volunteers aged 18-65 (including 18 and 65) with a history of non cancerous pain (regardless of the cause); 2. The weight of male volunteers shall not be less than 50 kg, and that of female volunteers shall not be less than 45 kg. Body mass index (BMI) ranges from 19 to 26 (including 19 and 26); 3. When no analgesics were received, the average pain score in the past 24 hours was evaluated with the Digital Pain Scale (NRS) <= 4. The pain symptoms remained stable in the near future, and were predicted to remain stable throughout the study period; 4. Female volunteers have taken effective contraceptive measures within 14 days before screening, and all volunteers are willing to take effective contraceptive measures without pregnancy plan during the trial and within 6 months after the trial; 5. Be able to read, understand and sign the Informed Consent Form (ICF) voluntarily, and complete the study according to the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: 1.Abnormal conditions (including vital signs, physical examination, laboratory examination, 12-lead electrocardiogram) deemed clinically significant by the clinician and deemed unsuitable for participants by the investigator; 2.Heart rate <= 60 beats/min or systolic blood pressure <= 90 mmHg during screening; 3.abnormal liver and kidney function with clinical significance; 4.Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive; 5.have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic conditions (such as allergic to two or more drugs, foods such as milk or pollen), or known allergic to opioids such as sufentanil or naltrexone, or allergic to adhesives in the same patch (pressure sensitive glue, vitamin E) 6.Patients with respiratory diseases (respiratory insufficiency, SpO2 <= 95%, acute or severe bronchial asthma, sleep apnea syndrome); 7.Have a history of digestive system diseases (gastrointestinal obstruction, paralytic ileus); 8.History of neurological diseases (sequelae of cerebral infarction, including but not limited to abnormal respiratory rhythm hemiplegia, aphasia and limb paresthesia; Other central nervous system diseases, such as intracranial tumor, craniocerebral injury, intracranial hypertension caused by any reason, which may affect the respiratory center); 9.Any disease that interferes with drug absorption, distribution, metabolism, or excretion that the investigator considers inappropriate for participants; 10.Frequent history of nausea or vomiting caused by any cause; 11.Skin abnormality and/or skin disease on one or both lateral upper arms, including but not limited to: unhealed skin lesions, dermatitis, burns, tattoos, scars, etc. 12.The following drugs have been used, are being used or need to be used during the study within 14 days prior to administration:Monoamine oxidase inhibitors: such as isoniazid, isopropyl hydrazine, griseofulvin, furazolidone; 13.The following drugs have been used, are being used or need to be used during the study within 7 days before administration:CYP3A4 inhibitors: such as erythromycin, ketoconazole, itraconazole; Antagonism of verapamil, diltiazem and other calcium ions Agent; May inhibit CYP3A4 chemical drugs, Traditional Chinese medicine, Chinese patent medicine;CYP3A4 inducers: such as rifampicin, phenytoin sodium, carbamazepine; CYP3A4 may be induced by chemochemical and Chinese drugs Medicine, Chinese patent medicine;Drugs that have an inhibitory effect on the central nervous system, such as barbiturates, sedatives, tranquilizers, alcohol and others anesthetic;Anticholinergic drugs, diuretics, muscle relaxants; 14.Had a special diet (such as grapefruit and grapefruits containing products, chocolate, any food containing caffeine or rich in xanthine (such as animal liver), or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism, excretion, etc., within 48 hours prior to taking the study drug; 15.Have consumed any alcoholic product or have been screened for positive alcohol within 48 hours prior to use of the study drug; 16.Positive drug abuse screening; 17.Patients with a history of alcohol/tobacco abuse: Alcohol abuse: who consumed an average of more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL 40% spirits or 150 mL wine) during the 3 months prior to the trial, or who could not stop taking any products containing alcohol duri
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