Osteoarthritis, muscle pain, swelling or pain from trauma.
Conditions
Interventions
T-R group:Apply test preparation (T) and reference preparation (R) on the back once each for two cycles
R-T group:The reference preparation (R) and the test preparation (T) were applied to the back once each for two cycles
Sponsors
Taizhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily sign informed consent prior to the commencement of any study procedure; 2.Healthy male and female subjects over 18 years of age (including 18 years of age), both male and female; 3.Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI19.0~26.0kg/m2 range (including the critical value); 4.From the screening period to 3 months after the end of the trial, no pregnancy plan, voluntary use of effective contraception, and no sperm donation, egg donation plan; 5.Be able to communicate well with the researcher and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Have been or are currently suffering from any clinically serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that can interfere with the test results (such as bronchial asthma, osteoarthritis, etc.); 2.A history of allergies to drugs, foods or other substances, or a history of severe skin allergies to investigational drugs, adhesives or other transdermal products; 3.Unable to promise not to take a bath without authorization during the trial hospitalization, or not to apply patches, creams, emollients or other similar products to the skin at the application site 24h before the trial until the end of the last PK sampling; 4.Had a major surgical procedure within 3 months prior to the first use of the study drug, or had a procedure within 28 days prior to the first use of the study drug that the investigator determined would affect drug absorption, distribution, metabolism, or excretion, or planned to have surgery during the trial period; 5.Use of any drug (including vaccination) or health product (including Chinese herbal medicine) within 14 days prior to the first use of the investigational drug; 6.People who have used topical drugs on the back skin within 30 days prior to the first use of the study drug, or plan to use topical drugs on the back skin during the trial; 7.Any drug that inhibits or induces liver metabolism of the drug (e.g., inducers - barbiturates, carbamazepine, phenytoin, rifampin) used within 30 days prior to first administration of the investigational drug; Inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.); 8.Use of drugs that act on blood vessels (vasoconstrictors or vasodilators) or other drugs that may affect the efficacy or safety evaluation of the investigational drug (e.g. Nitroglycerin, antihypertensive drugs, antihistamines, nonsteroidal anti-inflammatory drugs, aspirin, and over-the-counter cough/cold medicines containing antihistamines and/or phenylpropanolamine or phentolamine); 9.Participants who have used or enrolled in any clinical trial drug within 3 months prior to their initial use of the investigational drug, or plan to participate in other clinical trials during the study period; 10.Blood donation or blood loss of more than 400mL (other than normal menstrual blood loss in women) within 3 months prior to the first use of the study drug, or receiving a transfusion, using blood products, or planning to donate blood or blood components during the study period; 11.Can not tolerate venipunctures and/or have a history of fainting blood, fainting needles or a tendency to severe bleeding; 12.Use of oral contraceptives within 30 days prior to first use of the study drug, or use of long-acting estrogen or progesterone injections or implants within 6 months prior to first use of the study drug; 13.People who have had unprotected sex in the 14 days prior to their first use of the study drug, or women who are pregnant or breastfeeding; 14.Subjects and their partners were unable to use one or more non-pharmaceutical contraceptive methods throughout the trial period, or had plans to have children and plan to donate sperm or eggs within 3 months after the end of the study; 15.Have special dietary requirements, can not comply with a unified diet or swallo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adhesion evaluation;Apparent total body clearance CL/F;Skin irritation evaluation;Peak concentration Cmax;Apparent volume of distribution Vd/F;Relative bioavailability F;Peak time Tmax;Apparent terminal elimination rate constant ?z;Apparent terminal elimination half-life t1/2;AUC0-T;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests: blood routine, blood biochemistry, urine routine, coagulation function, blood pregnancy (female only);Adverse events, drug combinations and non-drug treatments were observed and recorded;Vital signs monitoring (including ear temperature, pulse and sitting blood pressure);Electrocardiogram; | — |
Countries
China
Contacts
Public ContactXu luwei
Taizhou Hospital of Traditional Chinese Medicine
Outcome results
None listed