Pharmacokinetic study
Conditions
Interventions
Experimental group1:Reference preparation + test preparation
Experimental group2:Test preparation + reference preparation
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged 18 to 55 years, both men and women; 2. Male subjects weigh no less than 50 kg, female subjects weigh no less than 45 kg; body mass index (BMI) ranges from 19 to 28 kg/m2 (including cut-off values); 3. Subjects are healthy, no history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic diseases and other diseases effecting the study judged by researchers; 4. Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions. Volunteers are able to communicate well with researchers.
Exclusion criteria
Exclusion criteria: 1. Participated in any clinical trial within 90 days before the trial, or planned to participate in other clinical trials during the research period; 2. Have undergone major surgery within 90 days before the trial or plan to undergo surgery within 3 months after administration; 3. Lost blood or donated more than 300 mL of blood within 90 days before the test (excluding the blood loss of women during menstrual period), or received blood transfusion; 4. Those who have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, food and pollen), or allergic to the components of this medicine* or analogs; 5. Use of any drugs within 14 days before the trial, including the use of prescription drugs, over-the-counter drugs and/or alternative drugs (such as medicated diets, Chinese herbal medicines, hemostatic and blood-activating plants or health products), and the use of hormonal contraception or vaccines, or the investigator believes that it is not suitable to participate in the trial ; 6. Have a history of psychotropic substance abuse; 7. Positive drug abuse test (tetrahydrocannabinol acid, benzodiazepine, barbiturates, morphine, cocaine, methamphetamine); 8. Smoking more than 5 cigarettes per day on average within 90 days before the test; addicted to alcohol, women drink more than 7 drinks per week or men drink more than 14 drinks per week within 28 days before the test (1 glass = 150 mL of wine = 360 mL of beer = 45 mL of spirits); 9. Patients with impaired liver function, cardiac insufficiency, peptic ulcer, ulcerative colitis, Crohn's disease or with a past history; 10. Aspirin asthma (asthma attack induced by non-steroidal anti-inflammatory analgesics, etc.) or patients with a history of gastrointestinal bleeding or perforation after application of non-steroidal anti-inflammatory drugs; 11. Those with damaged skin, atopic dermatitis, eczema, rash, pigmentation and tattoos at the pre-applied site; 12. Positive alcohol breath test; 13. Body temperature (ear temperature) >= 37.5 degree, obvious abnormal breathing and the investigator considers it unsuitable to participate in the test, sitting systolic blood pressure > 140 mmHg or 90 mmHg or 100 times/min; 14. Human immunodeficiency virus (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C (anti-HCV) or syphilis antibody (TP) positive; 15. There are special requirements for diet, and the unified diet cannot be followed during the test; 16. Subjects refuse to comply with the prohibition of beverages and foods (including tea, chocolate, coffee, cola, etc.) containing caffeine, alcohol, and grapefruit 48 hours before taking the medicine; 17. Subjects with partners refuse to use effective contraception within 180 days from screening to the end of the study; 18. Positive pregnancy test for female subjects; 19. There are obvious abnormalities in the physical examination and the investigator considers it unsuitable to participate in the trial; 20. There are obvious abnormalities in the electrocardiogram examination and the researcher believes that it is not suitable to participate in the trial; 21. There are obvious abnormalities in blood biochemistry, blood routine, and urine routine examinations and the researchers believe that they are not suitable to participate in the trial; 22. Difficulty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak concentration;Area under the drug-time curve from zero to t;Area under the drug-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactChen Liping
Dongyang Hengdian Hospital
Outcome results
None listed