Depression
Conditions
Interventions
TR:test drug in the 1st period and reference drug in the 2nd period
RT:reference drug in the 1st period and test drug in the 2nd period
Sponsors
The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45, healthy male and female subjects; 2. Male subjects with weight =50kg, female subjects with weight =45kg; body mass index [BMI=weight (kg)/height (m)2] within the range of 19-28kg/m2; 3. subjects in healthy condition, without significant clinical symptoms or abnormal laborary test results of clinical significance; 4. Fertilizable female subejects agree to taken appropriate contraception methods since signing ICF to 6 months after study; male subjects agree to take appropriate contraception methods with their partner in the same period; 5. subjects have a fair understanding of the purpose, property, progress and adverse event that may happen, and volunteer to sign the ICF; 6. Subject are able to proceed a smooth Communication with researchers, and a good compliance to the requirements of the study. subject are willing to say at Phase I study wards according to rules.
Exclusion criteria
Exclusion criteria: 1. subject cannot tolarate veinpunture; 2. Subject allergic to the study drug or its ingredients; subject has history of allergy or belongs to allergic constitution; 3. Subject has/had any history of serious disease, including but not limited to digestive, cardiovascular, respiratory, urinary, musculoskeletal, endorine, nervous, hemotologic, immune system or metabolic disorder; 4. labotory test: hemotology, urinalysis, blood biochemistry, HbsAg, HCV antibody, HIV antibody, syphilis, chest X-ray, 12-lead ECG. Any of the above items is abnormal and determined clinical significant by researchers. 5. Female subjects under pregenancy, lactation, or cannot take conspective measures; 6. Male subjects cannot take conspective measures or his parter plans to get pregnancy in 6 months; 7. Disability mentally or legally; 8. Subjects has history of abusement of prescription/illegal drugs; 9. subject took over 5 cigarettes every day in the past 12 months, or cannot quit smoking during the study; subject drank frequently in the past 6 months, namely 14 unit alcohol every week( 1 unit =360ml beer with 5% alcohol, 45ml liquor with 40% alcohol, 150 ml wine with 12% alcohol); 10. Urine tests of drug abuse, alchol or smoking turn to be positive; 11. Subjects donated blood or experience an acute blood loss(over 400ml) 2 week prior to screening; subject participated in other clinical trial 3 month before screening; 12. suject had vaccination, any prescription or Chinese herbal medicine 4 weeks prior to first administration; subject took any OTC, food suppliment(including vitamin) 2 weeks prior to first administration; 13. subject refuses to stop any food or reverge with methylxanthine, such as caffeine (coffee, tea, coke, choclate) from 2 days before to the end of the study; 14. subject refused to stop any food or reverage with grapefruit from 7 days before to the end of the study; 15. subject has a big change in his/her diet or exercise; 16. subject insuitable to the study according to researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Countries
China
Contacts
Public ContactShentu Jianzhong
The First Affiliated Hospital, Zhejiang University
Outcome results
None listed