Knee Osteoarthritis
Conditions
Interventions
RT Group:Reference preparation in the first cycle, test preparation in the second cycle
TR Group:Test preparation in the first cycle and reference preparation in the second cycle
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for this study: 1. Subjects must have been informed of the trial details before participation, fully understood the trial's content, procedures, and potential adverse reactions, and voluntarily signed a written informed consent form; 2. Subjects must be able to communicate effectively with the investigator and comply with the protocol requirements to complete the trial; 3. Gender: Chinese male or female; 4. Age: >=18 years old; 5. Body mass index (BMI) must range from 19.0 to 26.0 kg/m^2 [BMI = weight/height^2 (kg/m^2)] (including boundary values). Male subjects must weigh =50 kg, and female subjects must weigh >=45 kg;
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will be ineligible to participate in the study: 1. Allergic constitution: allergy to two or more substances (e.g., dust, pollen, food, drugs, etc.); history of allergic reactions to soap, lotion, moisturizer, ointment, cream, cosmetics, adhesives, or latex; photosensitive skin type; or history of allergy to indomethacin or any drug components; or allergy to medical tape, adhesive dressings, or other skin patches; 2. Skin at the application site that is oily, recently shaved, damaged (e.g., cuts or shaving injuries), or inflamed (e.g., redness, rash, open ulcers); untreated skin diseases or conditions such as atopic dermatitis, psoriasis, vitiligo, or known conditions that alter skin appearance or physiological response (e.g., diabetes, porphyria); history of skin cancer (e.g., melanoma, squamous cell carcinoma, except for superficial basal cell carcinoma not involving the application site); 3. Significant differences in skin color between the two application sites; conditions at the application site that may affect patch adhesion, skin evaluation, or drug absorption (e.g., excessive hair, scars, tattoos, abnormal skin color, etc.); 4. Engagement in strenuous or contact sports within 24 hours before dosing; or unwillingness to avoid contact of the application site with water/solutions/solvents during patch use and to avoid sweating or activities that induce excessive sweating; 5. Unwillingness to avoid exposure of the application site to strong light (e.g., sunbathing, tanning, light therapy, etc.) during patch use and for 10 days after patch removal; 6. Unwillingness to avoid scrubbing, shaving, or using creams, lotions, or oily cosmetics on the application site 48 hours before dosing and during patch use; 7. Current clinically significant diseases, including but not limited to respiratory, circulatory, digestive, hematological, endocrine, immune, dermatological, neuropsychiatric, or otolaryngological diseases; 8. Current skin infection or history of specific dermatitis, atopic dermatitis, contact dermatitis, or skin irritation reactions to topical medications. 9. Current or history of aspirin-induced asthma. 10. Major surgery within 6 months before the first dose or planned surgery during the study period. 11. Clinically significant abnormalities in vital signs, physical examination, electrocardiogram, or laboratory test results. 12. History of hepatitis B, hepatitis C, HIV, or syphilis and/or clinically significant abnormalities in one or more of the four viral screening tests. 13. Blood loss (excluding physiological blood loss in females) or donation of >=200 mL of whole blood within 3 months before the first dose, or donation of blood components (e.g., plasma, platelets, peripheral blood stem cells, etc.) within 3 months. 14. Use of any drugs that alter liver enzyme activity (e.g., inducers—barbiturates, carbamazepine, phenytoin, dexamethasone, etc.; Selective Serotonin Reuptake Inhibitors antidepressants, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, etc.) within 30 days before the first dose. 15. Use of any medications (including prescription, over-the-counter, or herbal medicines) and health products within 14 days before the first dose, except for topical medications applied to non-application sites or locally acting eye drops. 16. Vaccination within 1 month before the first dose or planned vaccination within 1 month after
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Concentration;Area Under the plasma Concentration-time curve from administration to last observed concentration at time ;Area Under the plasma Concentration-time curve extrapolated to infinite time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time Of Maximum Concentration;Elimination rate constant;Half Life;Percentage of Extrapolated Area;Total Clearance;Apparent Volume of Distribution;Relative Bioavailability; | — |
Countries
China
Contacts
Public ContactDeng Yaping
Zhejiang Xiaoshan Hospital
Outcome results
None listed