pain
Conditions
Interventions
Experimental group:One upper arm is given the test drug
Control group:Blank control of the contralateral upper arm
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Chinese male or female volunteers aged = 18= 65 years old with a history of non-cancerous pain (regardless of etiology): male volunteers weighing no less than 50kg, female volunteers weighing no less than 45kg, and 19BMI <26 [Body mass index (BMI) = weight kg/(height m); Digital Pain Scale (NRS) score within 24 hours prior to enrollment =4; Pain symptoms were stable for 14 days prior to enrollment, and pain symptoms were relatively stable throughout the study period predicted by history4) stable; Female volunteers had effective contraception within 14 days prior to screening: all volunteers were willing to voluntarily use effective contraception without pregnancy planning during the trial and within 6 months after the end of the trial; Voluntarily sign an informed consent form (ICF) and be able to understand and complete the study in accordance with the protocol requirements.
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1) Previous or current circulatory system, endocrine system, nervous system (vertigo syndrome, stroke sequelae including but not limited to abnormal respiratory rhythm, hemiplegia, aphasia, limb paresthesia; Other central nervous system diseases such as intracranial tumors, craniocerebral injury, intracranial hypertension caused by any cause, etc. that may affect the respiratory center), digestive system (nausea, vomiting, gastrointestinal obstruction, paralytic intestinal obstruction, etc.), respiratory system (ventilatory insufficiency Sp02=95% bronchial asthma, chronic obstructive pulmonary disease, obstructive sleep apnea-hypopnea syndrome).Genitourinary system, hematology, immunology, any clinically serious disease such as psychiatric and metabolic abnormalities or any other disease that can interfere with the test results; 2) Abnormal skin and/or skin diseases on the outside of one or both upper arms, including but not limited to: dermatitis, burns, tattoos, leprosy, etc. 3) Have a history of allergies to drugs, foods or other substances; 4) Those who have undergone surgery within 4 weeks before the trial, or who plan to undergo surgery during the study, and have taken any drugs or health supplements (including Chinese herbal medicines) within 14 days before the trial; 5) Those who have been used, are being applied or need to apply the following drugs during the study within 7 days before administration: -CYP3A4 inhibitors: such as erythromycin, ketocom, itracon; verapamil, diltiazem and other calcium ion antagonists; chemical drugs, traditional Chinese medicines, and proprietary Chinese medicines that may inhibit CYP3A4; -CYP3A4 inducers: such as rifampicin, phenytoin, carbamazepine, chemical drugs that may induce CYP3A4, traditional Chinese medicines, proprietary Chinese medicines; 6) A drug that has a depressing effect on the central nervous system: such as barbiturates, sedatives, tranquilizers, alcohol and other anesthetics; Primary anticholinergics, diuretics, muscle relaxants: 7) Those who participated in any clinical trial and took any clinical trial drugs within 3 months before the trial 8) Those who donated blood or lost a large amount of blood (> 200 mL, excluding menstrual blood loss in women) within 3 months before enrollment, received blood transfusions or used blood products; 9) pregnant or lactating women, as well as those who cannot use one or more non-pharmacological contraceptive methods during the volunteer trial; 10) Those who have special requirements for diet and cannot comply with a unified diet; 11) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup - 250mL) per day; 12) Patients with a history of alcoholism/tobacco addiction: 1. Alcoholism: 3 months before the test, an average of more than 14 units of alcohol per week (1 unit of 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of Portuguese wine), or could not stop taking any alcohol-containing products during the test, or those with a positive alcohol screen; 1. Tobacco addiction: 3 months before the test, the average daily smoking volume is more than 5, or the use of any tobacco products cannot be stopped during the trial; 13) Those who have consumed a special diet (such as grapefruit and grapefruit-containing products chocolate, any caffeinated, or foods rich in yellow quack (such as animal liver)) within 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration;Cmax;Tmax; | — |
Countries
China
Contacts
Public ContactGuoping YANG/Jie HUANG
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed