healthy subjects
Conditions
Interventions
TRTR:The test preparation was administered in period 1 and 3, and the reference preparation was administered in period 2 and 4
RTRT:The reference preparation was administered in period 1 and 3, and the test preparation was administered in period 2 and 4
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, methods and possible adverse reactions of the study, volunteer as a subject, and sign an informed consent form before the start of any trial procedure; 2. Male or female healthy subjects aged 18-50 years (including cut-off values); Male weight >= 50.0kg, female weight >+ 45.0kg; Body mass index (BMI) was in the range of 19.0-26.0 kg/m2 (including the cut-off value), body mass index (BMI) = weight (kg)/height 2 (m2); 3. Be able to communicate well with the researchers, and understand and comply with the requirements of this trial; 4. Female subjects did not plan to become pregnant and voluntarily took effective contraceptive measures (see Appendix 1 for details) and did not plan to donate eggs (sperm) from 2 weeks before signing the informed consent (from the first dose for male subjects) to 3 months after the last dose of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Those who have participated in other drug clinical trials and received drug administration within 3 months before screening; 2. There are certain allergic asthma, urticaria, eczema, etc.), or allergic constitution (such as to two or more drugs, food allergies), or a known allergy to this medicine composition or analogues, or to acetaminophen, diphenhydramine and methoxychlor amine injection, diazepam, or any phenothiazine allergies or specific reaction related compounds; 3. A history of depression, Parkinson's disease, epilepsy, or abnormal electroencephalogram; 4. Any cardiovascular system including coronary artery disease, myocardial infarction, arrhythmia or heart failure, etc.), digestive system, urinary system, respiratory system, blood system, endocrine system, immune system, nervous system, skeletal system, mental illness, such as the history of chronic or serious disease, the researchers think is still have clinical significance. 5. History of dysphagia or any gastrointestinal disease that affects drug absorption; 6. Lactose intolerant (such as drinking milk diarrhea), or have special requirements for diet, can not comply with the unified diet; 7. Those who cannot tolerate venipuncture, have a history of needle and blood dizziness, or fail the venous evaluation; 8. Patients who had undergone surgery within 3 months before screening, or planned to undergo surgery during the trial, and those who had undergone surgery that would affect drug absorption, distribution, metabolism, and excretion; 9. Those who have a smoking habit (at least 5 cigarettes per day) within 3 months before screening or cannot stop using any tobacco products during the test; 10. Those who have consumed more than 14 units of alcohol per week (1 unit = 285mL beer, 25mL 40% spirits, or 100mL wine) in the 3 months prior to screening; Those who cannot stop drinking any alcohol products 24 hours before the first dose and during the test; Alcohol breath test results > 0mg/100mL; 11. Blood donation or blood loss within 3 months before screening > 300mL (excluding menstrual blood loss), receiving blood transfusion or using blood products; Or planned blood donors during the trial and within 1 month after the end of the trial; 12. Any changes in gastrointestinal environment (e.g., proton pump inhibitors - teturazole, omeprazole, lansoprazole, esoprazole, etc.) taken within 30 days before screening; H2 antagonists - ranitidine, cimetidine, famotidine, etc. Antacid - sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc. Gastric mucosal protectants - sucralol, etc.) or liver enzyme activity drugs (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, dexamethasone, etc.; Inhibitors - SSRI antidepressants, ciprofloxacin, cimetidine, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, omeprazole, etc.); 13. Those who have received any substance with monoamine oxidase inhibitor (MAOI) activity, such as phenethylhydrazine, isoniazid, etc. within 28 days prior to screening; Drugs that can cause extrapyramidal reactions, such as phenothiazines, have been used within 28 days before administration; 14. Vaccinated within 30 days before screening; 15. Have used any prescription drugs in the 14 days prior to screening; 16. Has used any over-the-counter drugs, health products or Chinese herbal medicines within 48 hours before administration; 17. Excessive consumption of metabolically affecting food, including
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed