None listed
Conditions
Interventions
Group T:Give the test preparation first and then the reference reagent
Group R:Give the reference reagent first and then the test product
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Gender: healthy subjects, no gender limit; 2. Age: Chinese healthy volunteers between 18 and 60 years old (including the boundary value); 3. Weight: male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, body mass index [BMI=weight (kg)/height^2 (m^2)] within the range of 19.0 to 26.0 kg/m^2 (including boundary values); 4. The skin of the anterior thighs on both sides is normal and intact without damage; 5. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent; 6. The subject can communicate well with the investigator and can complete the research in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1. Those who have participated in any other clinical trials within 3 months before the trial; 2. Those who are allergic to amide local anesthetics such as lidocaine and prilocaine, any excipients in this product or medical tape, or those who are allergic to two or more drugs (or foods); 3. There is a history of cardiovascular (arrhythmia, etc.), liver, kidney, endocrine, digestive tract, blood system, respiratory system, malignant tumor, mental abnormality, serious infection, etc. judged by the investigator to be clinically significant, or those who have the above diseases ; 4. Patients with skin diseases (such as eczema, urticaria, atopic dermatitis, etc.) judged by the researchers to be clinically significant, or there are birthmarks, scars, tattoos, open wounds, or exuberant hair at the administration site (the skin on the front of both thighs); 5. Patients with previous or existing glucose-6-phosphate dehydrogenase deficiency and methemoglobinemia (inquiry); 6. Those with orthostatic hypotension, history of acupuncture or haemorrhage, or intolerance to venipuncture blood collection; 7. Those who have undergone surgery within 4 weeks before the trial, or those who plan to undergo surgery during the study period, and the investigator judges that it will affect the absorption, distribution, metabolism, and excretion of the drug; 8. Those who donate blood or lose >=400 mL of blood within 3 months before the first drug use in the study, or plan to donate blood or blood components during the study period or within 3 months after the end of the study; 9. Use of any drug that interacts with lidocaine, prilocaine (such as class III antiarrhythmic drugs (amiodarone), cimetidine or beta-blockers, etc.) or drugs related to methemoglobin-inducing drugs (such as sulfonamide, nitronitrofurantoin, phenytoin, phenobarbital, etc.) within 4 weeks before screening, or those who have been treated with topical dermatological drugs on the skin of bilateral front thighs within 4 weeks before screening; 10. Those who received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening or planned to receive inactivated/live/attenuated vaccine during the trial; 11. Those who have used any prescription drugs (except vaccines), non-prescription drugs, Chinese herbal medicines, and health products within 14 days before the test; 12. Those who drink too much (more than 8 cups a day, 1 cup = 200 mL) tea, coffee or caffeinated beverages within 3 months before the test; or those who ingest any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose of the study; 13. Those with an average daily smoking volume of more than 5 cigarettes in the first 3 months of the trial, and those who cannot accept smoking bans after enrollment to the entire trial period; 14. Frequent drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine); or unwillingness to stop drinking alcohol or any alcoholic products during the trial; 15. Those who cannot comply with a unified diet (such as intolerance to standard meals, etc.); 16. Drug abusers or those who have used soft drugs (such as marijuana) in the 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) in the 1 year before the test; 17. Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping, Xiang Yuxia
Outcome results
None listed