Osteoarthritis
Conditions
Interventions
Single administration Group C:Administer 100 mg
Administer100mg multiple times:Administer 100 mg
Single administration Group B:Administer 50 mg
Single administration Group A:Administer 25 mg
Administer50mg multiple times:Administer 50 mg
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1)Before the experiment, fully understand the purpose, nature, procedure of the experiment and possible adverse reactions, voluntarily become a subject, and sign the informed consent form; 2) Chinese healthy male or female subjects aged 18 to 55 years old (including the critical value); 3) The weight of both men and women is >=50.0 kg, and the body mass index (BMI) is within the range of 19.0-26.0 kg/m^2 (including the critical value); 4) The subjects had no plans for fertility, no plans for sperm or egg donation, and voluntarily adopted medically approved contraceptive measures within 6 months from the screening visit to the last administration, including but not limited to: correct use of male condoms and abstinence. Or intrauterine devices; Or either party has undergone sterilization.
Exclusion criteria
Exclusion criteria: 1) Those who have participated in any clinical trials within the 3 months prior to the screening; 2) Have had or are currently suffering from any serious clinical diseases in the cardiovascular system, endocrine system, nervous system (epilepsy), digestive system (peptic ulcer, gastrointestinal bleeding or perforation), respiratory system, urinary and reproductive system, blood system, immune system, psychiatric and metabolic disorders, infectious diseases, or any other diseases that can interfere with the test results. Or those with any other diseases that affect the trial process; 3) Those with a specific history of allergies (such as asthma, urticaria, eczema, etc.) or those with an allergic constitution (such as those known to be allergic to two or more substances), or those known to be allergic to ketorolac tromethamine, aspirin and other non-steroidal anti-inflammatory drugs; 4) Those with skin diseases judged by researchers as clinically significant (such as eczema, urticaria, dermatitis, etc.) or those with birthmarks, scars, tattoos, open wounds or excessive hair at the drug administration site; 5) Those who have undergone surgery within 6 months prior to the trial, as determined by the researcher, that would affect drug absorption, distribution, metabolism or excretion; Or those who have undergone surgical operation within 28 days before the trial, or plan to undergo surgical operation during the trial; 6) Those who have used any drugs or health supplements (including Chinese herbal medicines and vitamins) within 14 days prior to the trial; 7) Those who have donated blood or lost a large amount of blood (>=400 mL, except during the menstrual period of women) within 3 months before the test, or have received blood transfusion or used blood products; 8) Those who cannot tolerate venipuncture, or have difficulty in venous blood collection, or have a history of fainting from needles or blood; 9) Any drugs that inhibit or induce liver drug metabolism or selective serotonin reuptake inhibitors, aspirin or other non-steroidal anti-inflammatory drugs, probenecid, or hexanone theobromine have been used within one month prior to the trial; 10) Those who have received a vaccine within one month prior to the trial or plan to receive a vaccine during the study period; 11) Those who have special dietary requirements, cannot follow a uniform diet or have difficulty swallowing; 12) Those who consume excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day within 3 months before the experiment, or who cannot stop drinking tea, coffee or caffeinated beverages during the experiment; 13) Smokers or those who smoked more than 5 cigarettes a day within 3 months before the trial, or those who were unable to stop using any tobacco products during the trial; 14) Alcoholics or those who frequently consumed alcohol within 6 months prior to the trial, that is, those who drank more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine) or were unable to stop using any alcoholic products during the trial; 15) Drug abusers or those who have used soft drugs (such as marijuana) in the three months prior to the trial or taken hard drugs (such as cocaine, benzylhexperidine, etc.) in the one year prior to the trial; 16) Pregnant or lactating women, or those with abnormal blood pregnancy tests; 17) Those with positive tests for hepatitis B surface an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of skin irritation;Vital signs;Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lead 12- Electrocardiogram;Evaluation of adhesion force; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed