Relief of the pain
Conditions
Interventions
Fasting State:R or T
Fed State:R or T
Sponsors
Henan Xinxiang Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria before entering the trial: 1. Gender: healthy male and female subjects; 2. Age: over 18 years old (including 18 years old); 3. Body weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass index [BMI = weight (kg) / height 2 (M2)] should be in the range of 19.0-26.0kg/m2 (including boundary value); 4. Subjects who have passed medical history inquiry, relevant physical examination and laboratory examination; 5. Subjects who voluntarily participated in and signed the informed consent form met the requirements of GCP; 6. Subjects who can communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Subjects with any of the following could not be included in this study 1. Patients with abnormal vital signs, physical examination, blood routine, blood biochemistry, blood coagulation, urine routine, 12 lead ECG, HBsAg, HCV antibody, HIV antibody, Treponema pallidum antibody in the examination and judged clinically significant by the researchers; 2. Patients with chronic or serious diseases such as liver, kidney, digestive tract, endocrine system (such as diabetes mellitus), cardiovascular and cerebrovascular system (such as stroke, heart or cerebral vein blockage, cerebral hemorrhage, etc.), nervous system, metabolic system, blood system (such as porphyria hepatica, coagulation disorder), respiratory system and autoimmune system, or existing diseases of the above systems; patients taking acetyl Patients with pulmonary muscle spasm, asthma attack, nasal mucosal swelling, urticaria or skin reaction after salicylic acid or other NSAID drugs (including diclofenac sodium sustained-release tablets), and patients not suitable for the group determined by the researchers; 3. Patients with peptic ulcer, gastric perforation, gastrointestinal bleeding history or above diseases and existing gastrointestinal discomfort; 4. Patients with history of mental illness, drug abuse and drug dependence; 5. Patients who have special requirements for diet and can not follow the unified diet, or patients with dysphagia; 6. Patients with allergic constitution, such as those who are allergic to two or more drugs or food, or known to be allergic to any component of diclofenac and excipients; 7. Those who drink too much tea, coffee or caffeinated beverages (8 or more cups a day on average, 1 cup = 250ml) within 3 months before screening; or those who take tea or any caffeinated food or beverage (such as coffee, chocolate, etc.) within 48 hours before the first administration; 8. Those who ingested a large amount of grapefruit rich beverage or food (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; or those who ingested any grapefruit rich beverage or food within 48 hours before the first administration; 9. Those who can't tolerate venous indwelling needle for blood collection or syncope; 10. In the three months before screening, the subjects who drink more than 14 standard units per week on average (1 standard unit contains 14 g alcohol, such as 360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine); the subjects who have positive alcohol test results on the day of occupancy; 11. In the first 3 months, the subjects whose average daily smoking amount was more than 5 cigarettes were screened; 12. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 14 days before screening; 13. The subjects who had participated in other clinical trials within 3 months before screening; 14. Those who had blood donation history or massive bleeding (> 400ml) in the first 3 months were screened; 15. Those who were screened for drug abuse (morphine, tetrahydrocannabinolic acid, methamphetamine, dimethyldioxoamphetamine, ketamine) on the day of admission; 16. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects have family planning during the whole trial period and within 3 months after the end of the study, and they are not willing to take one or more non drug contraceptive measures (such as complete abstinence, condo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in blood;AUC0-t, AUC0-8, Cmax;Tmax, t1/2, ?z;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactTiandong Zhang
Xinxiang Central Hospital
Outcome results
None listed