For the following diseases and symptoms, it provides anti-inflammatory and analgesic effects: Osteoarthritis, periarthritis of shoulder, tendinitis and tenosynovitis, peritendinitis, lateral epicondylitis of humerus (tennis elbow), muscle pain, swelling and pain caused by trauma.
Conditions
Interventions
R-T group:
22/1000
The first cycle uses a reference preparation
Use the test formulation in the second cycle.
T-R group:The first cycle uses the test formulation
Use the reference formulation in the second cycle.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participants should be healthy men and women aged between 18 and 55 (inclusive of 18 and 55). 2. The male participants should have a body weight of no less than 50.0 kg, and the female participants should have a body weight of no less than 45.0 kg. Eligibility criteria: Body mass index range (BMI) 19.0 - 26.0 kg/m^2 [BMI = weight (kg) / height (m)^2 ] (including 19.0 and 26.0); 3. Possess the ability to communicate normally with researchers/medical staff and abide by the relevant hospital regulations. 4. The participants fully understand the purpose, nature, methods of the trial, as well as the possible adverse reactions. They voluntarily participate and sign the informed consent form before any research procedures commence. 5. Participants must agree to refrain from using non-medical forms of contraception for the 14 days prior to screening, during the trial period, and for the next 3 months after the study concludes, in order to avoid pregnancy or causing their partners to become pregnant or donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. Individuals with allergic constitution, such as those who have a known history of allergy to two or more medications, or those who have a previous history of allergy to Flurbiprofen patches and their related excipients; 2. Patients with aspirin-induced asthma (asthma triggered by non-steroidal anti-inflammatory drugs, etc.) or those with a previous history of asthma; 3. Patients with any conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage; 4. Individuals with skin conditions such as eczema, rash, contact dermatitis, psoriasis, seborrhea, moles, scars, abnormal pigmentation, carbuncles, injuries, open wounds, excessive sun exposure, or tattoos, and those whose conditions may affect the safety of the trial or the trial results; 5. Individuals with obvious differences in skin color, excessive hair growth, scar tissue, tattoos, coloring, or those with skin diseases such as atopic conditions, psoriasis, vitiligo or diseases known to alter the appearance or physiological response of the skin (such as diabetes, porphyria); 6. Exclude those who have suffered from acute diseases within the past two weeks. 7. Any medical history that may affect the safety of the trial or the body's process of drug absorption, including but not limited to mental and neurological disorders, cardiovascular system diseases, blood and lymphatic system diseases, immune system disorders, digestive system diseases, urinary system diseases, respiratory system diseases, endocrine and metabolic system diseases, and musculoskeletal system diseases; 8. During the screening process, physical examination of vital signs, general physical examination, clinical laboratory tests (complete blood count, routine urine test, blood biochemistry, four items of coagulation function, four items of infection tests), and twelve-lead electrocardiogram examination were conducted. The results showed abnormalities, and those judged by the research doctor to be clinically significant were included. 9. Exclude those who have undergone surgeries within the past 6 months and whose surgeries, as determined by the investigators, would affect the absorption, distribution, metabolism, or excretion of the drug, or those who plan to undergo surgeries during the study period. 10. Exclude those who have received vaccination within the past 4 weeks, or those who plan to receive any vaccination during the trial period; 11. Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal preparations and formulas, etc.), health supplements, or functional vitamins within the past two weeks; 12. Select those who have participated in other clinical trials within the past three months and who are currently taking the medication. 13. Select those who have donated blood within the past 3 months, and those whose total blood loss due to blood donation or other causes within 6 months has reached or exceeded 400 mL (excluding blood loss during women's menstrual periods). 14. Exclude those who had a history of alcohol abuse within the previous year, that is, those who consumed an average of more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine), or those whose alcohol breath test result was greater than 0.0 mg/100 mL, or those who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC_%Extrap;Adhesion evaluation;t1/2;Evaluation of skin reactions;Tmax;Safety evaluation indicators;?z; | — |
Countries
China
Contacts
Public ContactDaniel Duan
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed