Rheumatoid arthritis, arthralgia and arthritis, neuralgia and neuritis backache, cervico brachial syndrome, uterine appendages, dysmenorrhea, erythema (erythema nodosum, erythema multiforme exudation, erythema annularis centrifugalis)
Conditions
Interventions
Fasting T-R group:Take 1 sachet of the test preparation or reference preparation once per cycle on an empty stomach
Fasting R-Tgroup:Take 1 sachet of the test preparation or reference preparation once per cycle on an empty stomach
After meals T-R group:Take 1 sachet of the test preparation or reference preparation as a single time after a meal per cycle
After meals R-T group:Take 1 sachet of the test preparation or reference preparation as a single time after a meal per cycle
Sponsors
Panyu District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily act as a subject, and sign the informed consent form by myself before the start of any research procedure and ensure that I participate in the trial throughout the trial process; 2. Men and women aged 18~65 (including 18 and 65 years old), with appropriate sex ratios; 3. Male weight = 50.0kg, female weight = 45.0kg; body mass index (BMI) in the range of 18.5~26.0kg/m2 (including critical value); 4. Vital sign examination, physical examination, clinical laboratory examination (blood routine, urine routine analysis, blood biochemistry, blood transfusion, coagulation function, blood pregnancy test (women)), alcohol breath test, drug abuse screening, 12-lead ECG results show no abnormality or abnormal and no clinical significance; 5. No pregnancy plan during the screening period and the next 3 months and voluntary use of effective contraceptive measures (Appendix 2) and no sperm or egg donation plan; 6. Able to communicate well with the researcher, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any drugs, food, etc., or has a history of specific allergic reactions (such as asthma, rubella, eczema dermatitis) or is a severe allergic constitution, and is judged by the researcher to have clinical significance; 2. Those with a history of dysphagia or any gastrointestinal disease that affects the absorption of drugs; 3. Have a history of any chronic or serious diseases such as any circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic abnormalities, or any other diseases that may interfere with the test results, or a history of surgery within 3 months; 4. Those with poor vascular puncture conditions, or those who cannot tolerate venipuncture, or those who have a history of needle sickness and blood sickness; 5. Those who have a history of drug abuse within 6 months before screening, or those who have used drugs within 3 months before screening, including repeated and heavy use of various narcotic drugs and psychotropic substances for non-medical purposes, or urine addictive drugs morphine, methamphetamine (ice), ketamine, methylenedioxyamphetamine (ecstasy), tetrahydrocannabinol acid (marijuana) screening tests with positive results in any one or more of them; 6. Those who have participated in or are participating in other drug clinical trials within 3 months before screening; 7. Those who donate blood within 3 months before screening, including component blood or large blood loss (= 400mL), receive blood transfusion or use blood products; or those who intend to donate blood (including blood components) during the test or within 3 months after the end of the test; 8. The female is pregnant, lactating, or the woman has unprotected sex or a positive blood pregnancy test result within 14 days before the planned administration; 9. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and vitamins within 14 days before screening; 10. Those who have received vaccination within 4 weeks before screening or those who plan to be vaccinated during the trial; 11. Those who smoked more than 5 cigarettes per day within 3 months before screening, or could not stop using any tobacco products during the trial; 12. Alcohol intake in the 3 months prior to screening exceeded an average of 2 units per day (1 unit = 360mL of beer, or 150mL of red wine, or 45mL of distilled spirit), or positive alcohol test, or those who did not agree to avoid drinking during the test; 13. Excessive consumption of strong tea, coffee and/or caffeinated beverages per day for 3 months before screening (more than 8 cups, 1 cup = 250mL); 14. Those who have ingested strong tea, chocolate, coffee or food or drinks containing caffeine, alcohol, xanthines (such as anchovies, sardines, beef liver, beef kidney, etc.), grapefruit (juice) or grapefruit (juice) within 48 hours before taking the drug; 15. Those who have special requirements for diet and cannot accept a unified diet (such as unable to tolerate milk, eggs, butter, bacon and other foods); 16. Those whose physical examination and vital signs examination are abnormal and judged to be clinically significant by clinicians; 17. Laboratory examination, 12-lead ECG is abnormal and clinically judged by clinicians; 18. Human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, treponemal antibody (Anti-TP) any one or more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactSu Jianfen
Guangzhou Panyu District Central Hospital
Outcome results
None listed