Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy male or female, aged >= 18 years; 2. Male body weight >= 50 kg, female weight >= 45 kg, body mass index (BMI) between 19 and 26 kg / m2 (BMI = weight (kg) / height 2 (M2)), including the boundary value; 3. People who voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who took any other clinical trial drug or took part in any other drug clinical trial within 3 months before the study; 2. Subjects who have a history of allergy to drugs (such as Aripiprazole or any substance in this preparation) or allergic constitution; 3. Subjects with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, diverticulitis, enteritis, active gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal surgery within 3 years; 4. History or at present suffering from any serious clinical disease, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry(any psychiatric history or family history,such as Alzheimer's disease history, epilepsy history, etc.) and metabolic disorders; 5. History or at present suffering from postural hypotension; 6. History of dystonia, family history of dystonia, or drug-induced dystonia; 7. History or at present taking psychotropic and antiepileptic drugs; 8. Subject with depression, anxiety and other mental diseases; 9. Subjects who have had an surgical procedure during 4 weeks before the study or planned surgery during the study; 10. Treatment of any medicine (including Chinese herbal medicine and health products) within 14 days before the study; 11. Treatment of any drug that inhibited or induced the metabolism of the liver (such as the inducer-barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole, inhibitor -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, and verapami, fluoroquinolones, antihistamine), any nitrate esters, alpha blocker drugs, PDE5 inhibitors and endothelin receptor antagonists 30 days before the study; 12. Treatment of aripiprazole within 42 days before the study; 13. Subjects who vaccinated within 3 months before the study, or planned to vaccinate during the study or 3 months after the study; 14. Subjects who donated blood or had the frequency of blood loss of > 200 mL within 3 months before the study; 15. Subjects who are unable to take one or more contraceptive measures before the 2 weeks of study, during the trial and 6 months after the trial, and who are pregnancy, sperm donation and egg donation planners; 16. Subjects who need drive and operate dangerous machinery during the test period or 1 week after the trial; 17. Subject with vasovagal syncope, poor venous and vascular conditions or difficult puncture; 18. Subjects who have special requirements for diet, and can not comply with a unified diet; 19. Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day, and do not agree to stop drinking during the study; 20. Smokers or those who smoke more than 5 cigarettes per day 3 months before the study, and do not agree to stop smokeing during the study; 21. Drinkers or those who drink frequently 6 months before the study, that is, drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of alcohol with 40% of alcohol or 150 mL of wine), and do not agree to stop drinking during the study; 22. Drug abusers or those who used soft drugs (such as cannabis) 3 months before the start of study or those who took hard drugs (such as cocaine, phencyclidine, etc.) 1 years before the start of study; 23. Subjects with abnormal in vital signs ar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Changsha Ruiyi Pharmaceutical Technology Co., Ltd
Outcome results
None listed