Analgesia and anti-inflammatory of the following diseases and symptoms: osteoarthritis, scapulohumeral periarthritis, tendon and tendinitis, peritendinitis, external humeral epicondylitis (tennis elbow), muscle pain, swelling, pain caused by trauma.
Conditions
Interventions
A:Flurbiprofen gel paste, T-R
B:Flurbiprofen gel paste, R-T
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) The subject must give informed consent to the experiment before the experiment, fully understand the experiment content, process and possible adverse reactions, and voluntarily sign a written informed consent; 2) The subjects were able to communicate well with the researchers and complete the experiment according to the protocol; 3) Gender: male and female; 4) Age: 18 years old and above; 5) Weight: male weight >= 50kg, female weight >= 45kg, and body mass index [BMI= weight (kg)/height 2 (m2)] within the range of 19.0~26.0kg/m2 (including boundary value).
Exclusion criteria
Exclusion criteria: 1) Have a history of allergy (asthma, urticaria, eczema, etc.), or are known to be allergic to any ingredient in non-steroidal anti-inflammatory drugs and excipients such as flurbiprofen or medical tape, adhesive dressing or other skin paste; 2) have any medical condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and have a history of active pathological bleeding or intracranial bleeding; 3) Patients with gastrointestinal spasm, gastrointestinal ulcer, urinary tract infarction, mechanical intestinal obstruction, ureteral spasm, biliary tract disease, liver and kidney disease or other gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism; 4) Circulatory system, endocrine system, nervous system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or history of any clinical serious diseases or malignant tumors, or any other diseases or physiological conditions that can interfere with the test results; 5) Use of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbs, functional vitamins, health products) within 2 weeks before screening; 6) Drugs that overstrongly inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole) were used within 30 days before screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Drugs that overstrongly inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole) were used within 30 days before screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 7) Use of soft drugs (such as cannabis) within 3 months prior to screening or use of hard drugs (such as morphine, methamphetamine, etc.) within 1 year prior to screening; 8) Those who had undergone surgery within 6 months prior to screening or planned to undergo surgery during the study period; 9) Significant skin color differences on the back, excessive hair, scar tissue, tattoos, coloring, or accompanying skin diseases, such as atopic states, psoriasis, vitiligo, or diseases known to alter the appearance or physiological response of the skin (e.g., diabetes, porphyria), which may interfere with the application of the paste or hinder evaluation; 10) Open wound at the application site (back); 11) Apply topical medicine to the application site (back) for 7 days before administration; 12) Patients with aspirin asthma (asthma induced by non-steroidal anti-inflammatory drugs, etc.) or with a history of asthma; 13) People who donated blood or lost more than 200mL of blood for other reasons or used blood products or transfusions within 3 months before screening; 14) Those vaccinated within 14 days prior to screening; 15) Participants who have participated in other clinical trials and used investigational drugs within 3 months before screening; 16) Have a history of needle fainting or can not tolerate venous puncture blood collection; 17) Smokers or those who smoke more than 5 cigarettes per day on average, or those who do not agree to avoid the use of any tobacco products during hospitalization; 18) binge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t:;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAE;Tmax;?z;T1/2z;AUC_%Extrap;AE;Adhesion assessment;Skin reaction assessment:; | — |
Countries
China
Contacts
Public ContactDaniel Duan
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed