fever, pain, migraine and dysmenorrhoea
Conditions
Interventions
Sponsors
Guangzhou Panyu Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy male or female subjects, aged 18-45 (including 18 and 45); 2. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index within the range of 18.5-26.0 (including the critical value); male body weight >= 50 kg, female body weight >= 45 kg; 3. Health status: no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, nervous, and gastrointestinal systems; 4. Comprehensive physical examination, laboratory examination, abdominal B-ultrasound, and electrocardiogram all show normal or abnormal without clinical significance (subject to the investigator's judgment), and the investigator believes that the subject's health is in good condition; 5. Subjects must fully understand and voluntarily sign the informed consent form for this study; 6. The subjects or their partners must be willing to use medically acceptable contraceptive methods from the signing of the informed consent form to the end of the trial within 3 months, and the subjects cannot use contraception from the signing of the informed consent form to the end of the trial drug; 7. The subjects can communicate well with the researchers and complete the research according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or known allergy to ibuprofen; 2. The researchers believe that there are clinically significant cardiovascular, blood, liver, kidney, endocrine, respiratory (especially bronchial asthma), digestive (especially ulcer history), nervous, mental, immune, skin and metabolic disorders and other diseases or any other diseases or have the medical history and symptoms of these diseases, or factors that will endanger the safety of the subjects or affect the research results, or have had a history of major surgery; 3. Those who have undergone surgery within 3 months before the trial, or plan to undergo surgery during the trial; 4. Hepatitis B surface antigen positive, or hepatitis C antibody positive, or syphilis test positive, or HIV antibody test positive; 5. Pregnant, lactating women, or women of childbearing age who have a positive blood pregnancy test before the test; 6. Female subjects have pregnancy plans from 30 days before the administration to 3 months after the end of the study; male subjects and their partners have pregnancy plans within 3 months after the end of the test; 7. Have a history of drug abuse or a positive drug abuse screening; 8. Habitually taking any medicine (including Chinese herbal medicine) or functional vitamins; 9. Take any prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc. within 14 days before screening; 10. Those who drink >= 14 units of alcohol per week within 3 months before screening: 1 unit = 285 ml of beer, or 25 ml of spirits, or 250 ml of wine; or those who have a positive alcohol test at the time of screening, or those who cannot stop drinking during the test; 11. History of smoking within 3 months before screening (smoking more than 5 cigarettes or equivalent amount of tobacco per day); 12. People who are used to drinking excessive tea, coffee and or caffeinated beverages (average more than 8 cups per day, 200 mL per cup) or cannot be interrupted during the test; 13. Have special requirements for diet and cannot follow a unified diet (such as intolerance to high-fat diet, etc.); 14. Those who have participated in other clinical trials and taken their experimental drugs within 3 months before screening, or those who are participating in other clinical trials; 15. Blood donation or massive blood loss (>= 200 mL) within 3 months before screening; 16. Those who cannot tolerate venipuncture, or have a history of dizziness of needles and blood, or have difficulty in venous blood collection; 17. Patients with acute diseases during the pre-test screening stage or before the test drug; 18. Any other factors considered by the investigator to be inappropriate for the subject to enter this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of ibuprofen; | — |
Countries
China
Contacts
Public ContactYang Hui
Guangzhou Panyu Central Hospital
Outcome results
None listed