Postherpetic neuralgia
Conditions
Interventions
RT group:The reference preparation is used for the first period, and the test preparation is used for the second period
TR group:Subjects use the test preparation in the first cycle and the reference preparation in the second cycle
Sponsors
Haikou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 43 Years
Inclusion criteria
Inclusion criteria: 1) Before the test, the subject must have informed consent to the test, fully understand the test content, process and possible adverse reactions, and voluntarily signed a written informed consent form; 2) The subject can communicate well with the researcher and complete the test according to the protocol; 3) Gender: Chinese male or female; 4) Age: >= 18 years old; 5) The body mass index range is 18.6~28.5 kg/m^2 [body mass index=weight/height^2 (kg/m^2)] (including the boundary value). The weight of men is not less than 50 kg (including 50 kg), and that of women is not less than 45 kg (including 45 kg).
Exclusion criteria
Exclusion criteria: 1) Allergic constitution: people who are allergic to two or more substances (dust, pollen, food, drugs, etc.); Have had a major allergic reaction to soap, lotion, skin cream, ointment, cream, cosmetics, adhesives or latex; Skin type sensitive to sunlight; Or has a history of allergy or allergic reaction to lidocaine, tetracaine or amide or ester anesthetics or the ingredients contained in the patch; Or allergic to medical tape, adhesive dressing or other skin patches; 2) People with the following diseases with clinical significance (including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, nervous system, ENT and other related diseases); 3) Patients with any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, and patients with active pathological bleeding or history of intracranial hemorrhage; 4) Those who have undergone major surgery within 3 months before screening, or who plan to undergo surgery during the trial, or who have undergone surgery that will affect drug absorption, distribution, metabolism and excretion; 5) The results of various vital signs, physical examination, ECG examination and laboratory examination (blood biochemistry, blood routine, urine routine, blood coagulation function) show abnormalities with clinical significance; 6) Those who have one or more abnormalities of hepatitis B, hepatitis C, AIDS, syphilis and/or infectious diseases with clinical significance; 7) Blood loss (except female physiological blood loss) or blood donation greater than 200mL within 3 months before the first administration, and/or platelet donation within 2 weeks; 8) Use any over-the-counter medicine, Chinese herbal medicine or health care products within 7 days before the first administration; Or use any prescription drug within 14 days before the first administration; 9) Drugs that affect liver drug enzymes (such as phenobarbital, phenytoin, rifampicin, glumide, griseofulvin, cimetidine, ketoconazole, chloramphenicol, isoniazid, etc.) were used within 28 days before the first administration; 10) Those who have been vaccinated within 1 month before the screening or plan to vaccinate during the trial; 11) Those who have used any clinical trial drug within 3 months before the first administration; 12) Those who are positive in urine drug screening or have used drugs in the past or within three months before screening; 13) Those who smoke more than 5 cigarettes per day on average within 3 months before screening or those who do not agree to avoid using any tobacco products 48 hours before administration and during hospitalization; 14) Those who regularly drink alcohol within 6 months before screening, i.e., those who drink more than 14 units of alcohol every week (1 unit=360 mL of beer with 5% alcohol content, 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), or do not agree to stop drinking alcohol 48 hours before administration and during hospitalization, or those who have positive breath alcohol test; 15) Those who drink too much tea, coffee and/or caffeinated drinks every day within 3 months before screening (more than 8 cups, 1 cup=250mL) or those who do not agree to take tea, coffee and/or caffeinated food, grapefruit (grapefruit) and/or grapefruit juice (grapefruit juice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pharmacokinetic evaluation indexes: Cmax, AUC0-t, AUC0 - 8, etc. of lidocaine in plasma;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lidocaine in plasma Tmax,t1/2, ? z; | — |
Countries
China
Contacts
Public ContactHe Xiaoai
Haikou People's Hospital
Outcome results
None listed