Health Study Participants
Conditions
Interventions
T-R:First Period: Formulation T, Second Period: Formulation R
T-R:First Period: Formulation R, Second Period: Formulation T
Sponsors
Hunan Women's and Children's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese participants aged >=18 years, both male and female; 2. Male participants weighing at least 50 kg and female participants weighing at least 45 kg; Body Mass Index (BMI) in the range of 19-27.0 kg/m^2(including threshold values). Body mass index (BMI) = weight (kg)/height ^2(m^2); 3. Signed an informed consent form before the trial and fully understood the trial content, procedure and possible adverse effects; 4. Participants were able to communicate well with the investigator and understood and complied with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial with a test drug within 90 days prior to the trial; (ask for consultation+ network screening) 2. Allergy to any of the components of the product or to non-steroidal anti-inflammatory drugs (NSAIDs), or allergy to products containing thiophenic acid, slofen, phenylpropionic acid, oxybenzone, oxybenzene propene (e.g., sunglasses, perfume, etc.), or a history of a specific allergy (e.g., urticaria, asthma, eczema, etc.), or who have ever had itchiness, erythema, eczema that could constitute a clinical problem due to the application of patches (including tapes), or photosensitization; (ask for consultation) 3. Patients with aspirin asthma (asthma induced by non-steroidal anti-inflammatory drugs, etc.) or those with a previous history of asthma; (ask for consultation) 4. Presence of skin conditions such as excessive hair, tattoos, eczema, rashes, contact dermatitis, lichen planus, seborrhea, alien nevi, scars, pigmentation abnormalities, packs of boils, traumas, open wounds, oily skin texture, etc., or excessive differences in chromaticity of symmetrical anatomical areas of the site of intended administration or excessive sun exposure; (Ask for Consultation+ Physical Examination) 5. History of severe skin disease (e.g., psoriasis, vitiligo, lupus erythematosus, etc.) or diseases known to alter the appearance of the skin (e.g., diabetes mellitus, porphyria, etc.) or a previous history of such diseases; (ask for consultation) 6. A history of cardiovascular, endocrine, urologic, neurologic, hematologic, metabolic abnormalities, conditions that severely affect the immune response (e.g., primary or acquired immunodeficiencies, such as HIV or AIDS; allergic disorders, such as anaphylactic reactions, asthma, or systemic drug reactions; neoplasms, such as lymphomas or leukemias; rheumatoid arthritis; or systemic lupus erythematosus) that, in the opinion of the investigator, are of continuing Those who have clinical significance; (ask for consultation) 7. history of postural hypotension, intolerance of venipuncture, needle or blood sickness; (ask for consultation) 8. Use of any medication for any reason within 2 weeks prior to the trial (including herbs, supplements, etc.); (ask for consultation) 9. Those who have used any drug that inhibits or induces hepatic metabolism of drugs within 30 days prior to the trial (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRIs (selective serum reuptake inhibitors) antidepressants, ketoconazole, ritonavir, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) or other anticholinergic medications or other medications that have interactions (diclofenac sodium, fexofenadine, etc.) in those who (ask for consultation) 10. Blood donation or significant blood loss (=400mL) within 3 months prior to the trial; or planning to donate blood during the trial/within 1 month of the trial; (ask for consultation+ network screening) 11. Individuals who have undergone surgery within 3 months prior to the trial that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug; or who have undergone surgical procedures within 4 weeks prior to the trial; or who plan to undergo surgical procedures during the study period; (ask for consultation) 12. Substance abusers or those who have used soft drugs (e.g., marijuana)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak drug concentration (Cmax), area under the drug concentration-time curve (AUC0-t and AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak (Tmax), apparent elimination half-life (t1/2), apparent terminal elimination rate constant (?z), etc.; | — |
Countries
China
Contacts
Public ContactPeng Wenxing
Hunan Women's and Children's Hospital
Outcome results
None listed