fever, pain, migraine and dysmenorrhoea
Conditions
Interventions
Fasting - Group 1:Test preparation - reference preparation
Fasting - Group 2:Reference preparation - Test preparation
After dinner - Group 1:Test preparation - reference preparation
After dinner - Group 2:Reference preparation - Test preparation
Sponsors
Shulan(Hang Zhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All of the following Inclusion criteria need to be met: 1. Before the test, the subjects fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in the test and sign the informed consent. 2. Can complete research in accordance with the requirements of the pilot program. 3. Subjects (including partners) who do not plan to become pregnant and voluntarily use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the trial drug. 4. Healthy male or female, age 18 to 65 years, inclusive. 5. Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg, Body mass index (BMI) 18-28 kg/m2, inclusive. 6. No clinically significant abnormal findings at screening on physical examination, medical history.
Exclusion criteria
Exclusion criteria: Excluded if 1 exclusion criterion is met: 1.People with a history of specific allergies (asthma, measles, eczema, etc.) , or allergies (e.g. to pollen, two or more drugs/foods) , or who are known to be allergic to the ingredients or analogues of this drug; 2.Those who had undergone surgery within 3 months before screening, or who planned to undergo surgery during the trial; 3.Those who donated blood or had massive blood loss (=400 ml) within 3 months before screening, those who received a blood transfusion or used a blood product, or those who intended to donate blood or blood components during the trial or within 3 months after the end of the trial; 4.Smoked more than 5 cigarettes per day in the 3 months prior to the trial. 5.Regularly drank alcohol in the 6 months prior to screening (drinking more than 14 units per week: 1 unit ˜360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine). 6.tested positive for urinary drugs or had a history of drug abuse in the past five years 7.The following clinically significant diseases were found within 12 months before screening, including but not limited to neuropsychiatric, respiratory, cardio-cerebrovascular, digestive, blood and lymphatic, liver and kidney functions, endocrine system, and immune diseases) 8.Patients who had a history of gastrointestinal disorders (e.g. , chronic diarrhea, inflammatory bowel disease, acid reflux disease) within 12 months prior to screening and who the researchers considered still clinically relevant; Or severe vomiting or diarrhea within one week before screening; 9.Use of any of the following drugs (e.g. heparin, dicumarol, digoxin, methotrexate, hypoglycemic agents, furosemide, Antihypertensive drug, aminoglycosides, glucocorticoid, Antiplatelet drug, diuretics, lithium, quinolones, Zidovudine, selective serotonin reuptake inhibitor, etc.) within 28 days before screening; 10) took any prescription, over-the-counter, vitamin product or herbal medicine within 14 days of screening 10.Use of any medication within the 14 days prior to initiation of any prescription drug, over-the-counter drug, any vitamin product or herbal remedy. 11.Vaccinated within 4 weeks before screening 12.Had participated in other drug clinical trials and taken research drugs within 3 months before screening 13.Can not tolerate venipuncture, or have a history of fainting needle fainting blood, or blood collection difficulties 14.Have special dietary requirements (e.g. , vegetarianism, sucrose intolerance, high fat diet intolerance or lactose intolerance) and can not follow a uniform diet; 15. Consumed excessive amounts of tea, coffee or caffeinated beverages (8 or more cups, 1 cup = 250 ml) every day for 3 months before screening, or those who did not agree to stop drinking tea, coffee or caffeinated beverages during the trial 16.Those who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks prior to screening, or other factors that affect the absorption, distribution, metabolism, or excretion of drugs. 17. dysphagia 18.Those who have positive results for any of the tests: Hepatitis B Surface Antigen Qualitative Test, Hepatitis C Virus Antibody, Hepatitis C Virus Core Antigen, Human Immunodeficiency Virus (HIV) Antigen-Antibody Combination Test, and Syphilis Spirochete-Specific Antibody Test. 19. Female subjects who are breastfeeding or have a positive seropregnancy result during the screening period or during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;vital signs;12 lead electrocardiogram;laboratory examination; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan(Hang Zhou) Hospital
Outcome results
None listed