None
Conditions
Interventions
Fasting Group A:The subjects take the reference preparation in the first cycle and the test preparation in the second cycle.
Fasting Group B:The subjects take the test preparation in the first cycle and the reference preparation in the second cycle.
Postprandial group A:The subjects take the reference preparation in the first cycle and the test preparation in the second cycle after eating a high-fat meal.
Postprandial group B:The subjects take the test preparation in the first cycle and the reference preparation in the second cycle after eating a high-fat meal.
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 Healthy subjects, both male and female, aged 18-65 years old (including 18 and 65 years old); 2 Weight: male weight >=50.0kg, female weight >=45.0kg, body mass index (BMI) [BMI = weight kg/ (height m) 2] between 19.0 and 26.0kg/m2 (including boundary values); 3 Subjects (including male subjects) had no pregnancy plan within 3 months from the signing of informed consent to the end of the experiment. Men had no sperm donation plan and women had no egg donation plan, and they voluntarily took effective contraceptive measures during this period; 4 Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, are able to communicate well with researchers and complete the study in accordance with the study regulations, volunteer as subjects, and sign informed consent prior to the start of any study procedure.
Exclusion criteria
Exclusion criteria: 1. Participated in other drug clinical trials within 3 months prior to taking the investigational drug; 2 People with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (such as allergy to two or more drugs, food), and a history of allergy to indobuprofen tablets or adjuvants; 3 Patients with a history of chronic or acute diseases of the nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, immune system, and skeletal musculoskeletal system that the study physician determined might affect the study results; 4 There are coagulation disorders; 5 Patients at risk of bleeding, history of active ulcers or gastrointestinal bleeding, and history of active gastrointestinal disease; 6 People who are lactose intolerant (those who have had milk diarrhea); 7 Patients with tablet swallowing difficulty; 8 Difficulty in blood collection, fainting blood and fainting needles; 9 Patients who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the trial; 10 Persons who consumed more than 14 units of alcohol per week in the 6 months prior to screening (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or had consumed an alcoholic product within 2 days prior to taking the drug, or tested positive for an alcohol breath test; 11 Drug abuse screening positive or had a history of drug abuse in the five years prior to screening or had used drugs in the three months prior to taking the study drug; 12 People who had used any prescription, over-the-counter, herbal, or health products in the 2 weeks prior to taking the study drug; 13 Any drug that alters the activity of liver enzymes (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids) taken within 30 days prior to taking the study drug; Inhibitors - SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); 14 Those who received a vaccination within 1 month prior to taking the study drug; 15 Patients who had surgery within 3 months prior to taking the study drug, or planned to have surgery during the study period; 16 People who had significant blood loss (>=400 mL) within 3 months prior to taking the study drug, or had a history of blood donation within 3 months prior to taking the drug; 17 People who have consumed dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared from it within 48 hours before taking the study drug; 18 Eat and drink foods and beverages containing xanthines (caffeine, theophylline, theobromine, and Madyne), including coffee, tea, and chocolate, within 48 hours before taking the study drug; 19 People who had vigorous exercise within 48 hours before taking the study drug, or who could not stop vigorous exercise during hospitalization; 20 Female subjects were lactating during the screening period or during the trial or had a positive pregnancy test result; 21 Abnormalities judged by the study physician to be clinically significant, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination; 22 Other reasons that the investigator considered inappropriate for inclusion or subjects withdrew from the test for their own reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve;Peak concentration; | — |
Countries
China
Contacts
Public ContactYu Yanxia
Suzhou Municipal Hospital
Outcome results
None listed