None listed
Conditions
Interventions
Fasting test group A:Administered while fasting (three-cycle taking sequence: test preparation, reference preparation, reference preparation)
Fasting test group B:Administered while fasting (three-cycle taking sequence: reference preparation, test preparation, reference preparation)
Fasting test group C:Administered while fasting (three-cycle taking sequence: reference preparation, reference preparation, test preparation)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the experiment, voluntarily acts as a subject, and signs informed consent prior to the start of any study procedure; 2. Subjects aged 18-50 years (all including boundary values); 3. No gender limit, with appropriate gender ratio; 4. Male weight >=50.0 kg, female weight >=45.0 kg, body mass index (BMI) in the range of 19.0-26.0 kg/m^2 (all including boundary values); 5. The subjects were able to communicate well with the researchers and understood and complied with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Allergic to ibuprofen, norepinephrine or its excipients (microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose, colloidal silicon dioxide, hydroxypropyl cellulose, sodium dodecyl sulfate, talc powder, magnesium stearate, gastric soluble film coating agent, etc.); Have a history of allergy to two or more kinds of drugs or food; 2. History of dysphagia or any gastrointestinal disorder that affects drug absorption; 3. Have a history of mental and neuropathic diseases or family genetic history, such as epilepsy, depression, etc.; 4. Any surgical history, trauma history that may affect the safety of the trial or the in-vivo process of the drug, or plans to undergo surgery during the study; 5. Used any medicine or health care products or Chinese herbs within 2 weeks before screening; 6. Use of monoamine oxidase inhibitors (e.g., phenethylhydrazine, iscaporohydrazine, moclobemide, seregiline, bromofaromin, toloxadone, etc.) within 1 month prior to screening; 7. Use of drugs in the three months prior to screening; 8. Subjects with a history of drug abuse in the six months prior to screening; 9. Those who smoked more than 5 cigarettes per day in the 3 months before screening, or could not stop using any tobacco products during the test period; 10. Those who consumed more than 14 units of alcohol per week (1 unit =17.7mL ethanol, i.e. 1 unit =357mL beer with 5% alcohol or 43mL liquor with 40% alcohol or 147mL wine with 12% alcohol) in the 3 months prior to screening, or who could not abstain from alcohol during the test period; 11. Excessive consumption of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250mL) per day in the 3 months prior to screening, or cannot be interrupted during the trial; 12. Subjects who have participated in other drug clinical trials or participated in clinical trials other than themselves within 3 months prior to drug administration; 13. Subjects who donated blood including component blood or substantial blood loss (>=400 mL) in the 3 months prior to screening, received blood transfusion or used blood products, and planned to donate blood during the test period; 14. Those who were vaccinated within 1 month prior to screening or planned to be vaccinated during the study or within 1 month after the study; 15. The subject (female) is lactating; 16. The subject and his or her partner had plans for pregnancy or sperm or egg donation during the trial period (from the beginning of screening to 6 months after the trial ended) and were unwilling or unable to voluntarily use effective contraceptive methods; 17. Subjects who cannot tolerate venipunction and have a history of fainting needles and fainting blood; 18. Subjects who are lactose or fructose intolerant (who have experienced diarrhea from drinking milk); 19. Those who have special dietary requirements and cannot accept uniform diet; 20. Urine drug screening (morphine, ketamine, methamphetamine, dimethylene dioxyamphetamine, THC acid) positive or smoke test results positive; 21. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation function), 12-lead electrocardiogram, whose results show abnormal clinical significance; 22. Alcohol breath test results greater than 0.0mg/100mL; 23. Female subjects of childbearing age who have positive pregnancy test results during the screening period or during the test; 24. Acute illn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma concentration of ibuprofen;The concentration of norepinephrine in plasma; | — |
Countries
China
Contacts
Public ContactShi Shaojun
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed