Healthy Subjects
Conditions
Interventions
Efavirenz group:The remaining whole blood samples were taken from patients taking reference drug
Simvastatin group:The remaining whole blood samples were taken from patients taking reference drug
Aripiprazole group:The remaining whole blood samples were taken from patients taking reference drug
Paxoxetine group:The remaining whole blood samples were taken from patients taking reference drug
Risperidone group:The remaining whole blood samples were taken from patients taking reference drug
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, volunteers to be a subject, and signs the informed consent prior to the commencement of any study procedure, and warrants that he/she will participate in any study procedure; 2. Subjects can have good communication with the researchers, understand and comply with the requirements of this study; 3. Subjects have no history of chronic or serious diseases such as cardiovascular, liver, kidney, respiratory, blood, lymphatic, endocrine, immune, mental, neurological, gastrointestinal system and other diseases, and are in good general health condition; 4. Subjects (including male subjects) have no pregnancy plan during the screening period and in the next 6 months and are willing to take effective contraceptive measures and have no sperm or egg donation plan, among which non-drug contraceptive measures should be adopted voluntarily during the test; 5. Male and female subjects aged from 18 to 65 years old (including 18 and 65 years old), with appropriate sex ratio; 6. Male weight >= 50.0kg, female weight >= 45.0kg;Body mass index (BMI) ranges from 19.0 to 26.0 kg/m2 (including threshold) 7. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, four items of blood transfusion, coagulation function, pregnancy examination (female), drug screening, 12-lead electrocardiogram, results showing no abnormality or no clinical significance.
Exclusion criteria
Exclusion criteria: 1) Health status: medical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental and metabolic abnormalities, bone and other diseases with clinical significance; 2) Allergy history to test drugs or any drug components;Those who had a history of allergy and were judged unfit for inclusion by the researcher; 3) Lactose intolerant (had diarrhea from drinking milk); 4) A history of dysphagia or any gastrointestinal disease that interferes with drug absorption; 5) Those who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, and those who have undergone surgery that may affect drug absorption, distribution, metabolism and excretion; 6) Those who cannot tolerate venipuncture or have a history of fainting needles and blood; 7) Screening those with a history of drug abuse in the previous 6 months;Screening for drug use in the previous 3 months; 8) Screening blood donation including component blood or massive blood loss (>= 200mL) within 3 months before receiving blood transfusion or using blood products; 9) The subject (female) is pregnant or lactating during the screening period or during the test; 10) Subject has any family planning or sperm or egg donation plan during the screening period and in the next 6 months; 11) Screening for any drug (e.g., inducers -- barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole) that inhibits or induces hepatic drug metabolism within 28 days before treatment; SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 12) have used any prescription drugs, non-prescription drugs, Chinese herbs and dietary supplements/health products (including vitamins) within 2 weeks prior to screening; 13) Screening those who have received vaccination within 4 weeks prior to the study or plan to receive vaccination during the study period; 14) Screening for smoking more than 5 cigarettes per day in the previous 3 months, or not being able to stop using any tobacco products during the study period; 15) Screening of persons who have consumed more than 14 units of alcohol (1 unit of alcohol ˜360 mL beer or 45 mL of 40% alcohol spirits or 150 mL wine) per week during the first 3 months, or who cannot abstain from alcohol during the trial period; 16) Screen for excessive consumption of tea, coffee and/or caffeine-rich beverages (more than 8 cups per day, 1 cup =250 mL) per day in the previous 3 months; 17) Excessive consumption of dragon fruit, mango, pomegranate, kiwi, grapefruit, lime, star fruit or food or beverage prepared from them within 7 days prior to screening; 18) Those who have special requirements on diet and cannot accept a unified diet; 19) Screening those who have participated in the drug clinical trial and used the drug in the previous 3 months; 20) For abnormalities of vital signs with clinical significance, the range of normal values (including critical values) should be referred: sitting systolic blood pressure 90~139mmHg, diastolic blood pressure 60~89mmHg, pulse 60-100 times/min, body temperature (ear temperature) 35.4~37.7 degrees, respiration 16~20 times/min. The specific conditions should be determined by the researchers. 21) Laboratory examination and auxiliary examination of any item abnormal and clinically significant as determined by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the pharmacogenomics of health subjects; | — |
Countries
China
Contacts
Public ContactXianmin Meng
Shanghai Public Health Clinical Center
Outcome results
None listed