Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Fasting group1:In the morning of period I, participants received a single dose of test preparation after an overnight fast. In the period ?, participants crossed a single dose of reference preparation
Fasting group2:In the morning of period I, participants received a single dose of reference preparation after an overnight fast. In the period ?, participants crossed a single dose of test preparation
Feeding group1:In the morning of period I, participants received a single dose of test preparation after a high fat meal. In the period ?, participants crossed a single dose of reference preparation a
Feeding group2:In the morning of period I, participants received a single dose of reference preparation after a high fat meal. In the period ?, participants crossed a single dose of test preparation a
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects over 18 years old (including 18 years old), both male and female; 2. Male weight >= 50 kg; female weight >= 45 kg; body mass index in the range of 19~26 kg/m2 (including the critical value) (body mass index (BMI) = weight (kg) / height 2 (m2)); 3. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 4. The subjects can communicate well with the researcher, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. Those who participated in any clinical trial within 3 months before the trial and administered the trial drug; 2. Those with orthostatic hypotension or syncope in the past; 3. Those who have a medical history of the motor system, digestive system(such as pancreatitis, intestinal obstruction, etc.), respiratory system, urinary system, reproductive system, endocrine system, immune system, nervous system(such as psychosis, etc.) and circulatory system in the past and the researchers believe that there is still clinical significance; 4. Those with a history of previous seizures; 5. Those who are allergic to quetiapine fumarate or any other ingredients in this product, or have allergic constitution; 6. Driving, aerial work and machinery operators are required during the test,or athletes who need vigorous exercise; 7. Those who are intolerant to venipuncture or have a history of fainting blood or acupuncture; 8. Those who have undergone surgery that, as judged by the investigator, will affect the absorption, distribution, metabolism, and excretion of drugs within 6 months before the trial; or who have undergone any surgery within 4 weeks before the trial; or those who plan to undergo surgery during the study; 9. Those who have used any drugs (including Chinese herbal medicines, vitamins, thioridazine, phenytoin, etc.), health products, etc. within 14 days before the test; 10. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the test(including carbamazepine, barbiturates, rifampin, zole antifungals, macrolide antibiotics, and protease inhibitors); 11. Those who have been vaccinated within 14 days before the trial, or who plan to be vaccinated during the trial (including live attenuated vaccines and new crown vaccines); 12. Those who donated blood or lost a large amount of blood (>=200 mL, except women's menstrual period) within 3 months before the trial, or accepted blood products, or those who plan to donate blood or accepted blood products during the trial or within 3 months after the end of the trial; 13. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; 14. Smokers or those who smoked more than 5 cigarettes per day within 3 months before the trial, or those who do not agree to stop using any tobacco products during the trial; 15. Alcoholics or frequent drinkers within 6 months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); or disagree Those who stopped drinking alcohol or any alcoholic products during the trial; 16. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 17. Those who eat any diet (including dragon fruit, grapefruit or grapefruit products, grapefruit, orange, kale vegetables, charcoal roasted food, etc.) within 7 days before the experiment, or who have other diet that the researchers thought could affect the absorption, distribution, metabolism, and excretion of the drug; 18. Those with lactose intolerance, hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption (those who had diarrhea after drinking milk) or who are unable to eat high-fat meals as prescribed (for the feedi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak plasma drug concentration;Area under the drug concentration-time curve from 0 h to t h;Area under the plasma concentration-time curve from 0 h to infinity;peak time; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Boai Rehabilitation Hospital
Outcome results
None listed