local anesthetic
Conditions
Interventions
RTRT:According to the random table, the subjects applied 5 g of bupivacaine hydrochloride gel test formulation or reference formulation to one side of thei
TRTR:According to the random table, the subjects applied 5 g of bupivacaine hydrochloride gel test formulation or reference formulation to one side of thei
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial before the trial, voluntarily participate in this trial and sign the informed consent form; 2. The subject is able to communicate well with the investigator, understand and abide by the requirements of this study, and can complete the study in accordance with the requirements of the trial protocol; 3. Healthy subjects aged >=18 years, both male and female; 4. Male subjects weigh not less than 50 kg and female subjects weigh not less than 45 kg; Body mass index in the range of 19.0~26.0 kg/m^2 (including boundary value), body mass index (BMI) = weight (kg) / height 2 (m^2);
Exclusion criteria
Exclusion criteria: 1. Allergic to tetracaine and its analogues or any excipients in preparations, or allergic constitution (such as allergy to pollen, two or more drugs/foods) or have a history of severe allergies (such as allergic reactions, angioedema, rash, urticaria, etc.); 2. Those who have undergone surgery within 3 months before screening, or plan to undergo surgical procedures during the study; 3. Vaccination within 1 month before screening, or plans to be vaccinated during the study; 4. Those who have a history of needle sickness or hemosickness, or other factors known to cause difficulty in blood collection; 5. Regular alcohol consumption (drinking more than 14 units per week: 1 unit˜ 360 mL of beer or 45 mL of spirits or 150 mL of wine with an alcohol content of 40%) within 6 months before screening, or those who cannot give up drinking alcohol during the trial; 6. Those who smoke 5 cigarettes per day within 3 months = screening, or cannot give up smoking during the trial; 7. Use of soft drugs (such as marijuana) within 3 months before screening or hard drugs (such as morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, tetrahydrocannabinolic acid) within 1 year before dosing; 8. Those who have lost blood/donated blood to 400 mL or more within 3 months before screening (except for female menstrual blood loss), or have received blood transfusions or used blood products, or who intend to donate blood or blood components during the trial or within 3 months after the end of the trial; 9. Those who have had the following diseases in the past (including but not limited to the respiratory, circulatory, cardiovascular, digestive, hematological, endocrine, immune system, skin system, nervous system, otolaryngology, mental illness and other related diseases, especially severe skin diseases (such as psoriasis, vitiligo, lupus erythematosus) or diseases known to change the appearance of the skin (such as diabetes, porphyria, etc.), and are judged by the study doctor to still have clinical significance; 10. Excessive hair, tattoos, trauma, birthmarks, rashes, dermatitis, or other conditions that affect the administration or evaluation of the results of the investigational drug as judged by the investigator; 11. The area of the proposed administration site cannot meet the requirements of the administration area specified in the plan; 12. Those who have participated in any other clinical trial within 3 months before screening; 13. Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months before screening, or those who cannot stop drinking tea, coffee or caffeinated beverages during the trial; 14. Those who have a significantly abnormal/special diet (such as dieting, low-sodium diet), or have special requirements for food, cannot comply with a unified diet, or have difficulty swallowing; 15. Those who have eaten a diet that may affect the metabolism of drugs in the body (including grapefruit or grapefruit products, grapefruit, star fruit, pomegranate, mango, dragon fruit, chocolate, cabbage vegetables, xanthine-containing foods or drinks, etc.) within 7 days before screening, or do not agree to stop eating the above diet during the trial; 16. Topical preparations or physical therapy have been used at the site to be administered within 1 month before screening; 17. Those who have used any drugs (including Chinese herbal medicines, vitamins, etc.) or health care products within 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests (blood routine, blood biochemistry, urine routine); | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed