Pharmacokinetic study
Conditions
Interventions
Fasting group 1:R-R-T
Fasting group 2: R-T-R
Fasting group 3: T-R-R
Postprandial group 1:R-R-T
Postprandial group 2: R-T-R
Postprandial group 3: T-R-R
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged 25 years to 55 years old (including 25 and 55 years), both men and women; 2. Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg; body mass index 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; 4. Sign the informed consent form before the trial and fully understand the contents of the trial, process and possible adverse reactions. Subjects are able to communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials within 90 days before the study, or plan to participated in other clinical trials during the study; 2. Subjects who had major surgery within 90 days before this trial, or plan to surgery 3 months after the study; 3. Blood donation or massive blood loss (>300 mL), or received blood transfusion within 90 days before this trial; 4. Subjects with gastrointestinal diseases such as Esophageal reflux, stomach bleeding or peptic ulcer disease, heartburn occurs more than once a week, or any surgical procedure that may affect drug absorption (such as cholecystectomy)within 180 days; 5. Subjects who have a history of allergy to drugs (such as Aripiprazole or any substance in this preparation) or allergic constitution; 6. Treatment of any medicine (including Chinese herbal medicine and health products) within 28 days before the study; 7. Drug abuse history; 8. Positive result of urine screening test Tetrahydrocannabinolic acid, benzodiazepines, barbiturates, morphine, cocaine, methamphetamine); 9. Subject who smoke more than 5 cigarettes per day 90 days before the study, subjects who drink frequently 28 days before the study, that is, drinking more than 7 units of alcohol (female) or 14 units of alcohol (males) per week (1 unit =150 mL of wine =360 mL of beer = 45 mL of alcohol); 10. Positive result of alcohol breathing test results; 11. Temperature >= 37.5 degrees C, obviously abnormal breathing according to the physician's judgment, systolic blood pressure > 140mmHg or 90mmHg or 100 bpm; 12. Positive result of HIV-Ab, HBsAg, HCV, TP test; 13. Subjects who have special requirements for diet, and can not comply with a unified diet; 14. Subjects who eat foods including, caffeine, alcohol grapefruit, and the food in the 48h before taking the study drug; 15. Subjects with partners refuse to use effective contraception within 180 days from screening to completion of the study; 16. Women during pregnancy; 17. Subjects with mental disorders, closed-angle glaucoma disease; 18. Subjects with endocrine disease, renal impairment, hepatic impairment or decompensated disease of the heart; 19. Dizziness of needles, dizziness and difficulty in venous blood collection; 20. abnormal physical examination and according to the physician's judgment; 21. Obvious abnormalities in the electrocardiogram according to the physician's judgment; 22. Obvious abnormalities in blood biochemistry, blood routine, and urine routine examinations according to the physician's judgment; 23. Subjects with other reasons that the researchers according to the physician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactFeiyan Jin
Dongyang Hengdian Hospital
Outcome results
None listed