healthy volunteer
Conditions
Interventions
five:drug intervention
Sponsors
Xiyuan Hospital,CACMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged btween 18 to 50 years, half male and female;BMI between 19 to 25, men's weight>50kg, women's weight>45kg, similar body weight within the same batch; no positive signs of physical examination; no clinically abnormity of laboratory inspection and ECG test; informed consent and volunteered to participate the trial.
Exclusion criteria
Exclusion criteria: substance abuser, heavy smoker, alcoholist; subjects who had all sorts of drugs, health care products (including traditional Chinese medicine, homemade wine, etc.) two weeks ago;subjects who participated in clinical trials in recent 4 weeks; subjects who had medication with known organ lesions within 3 months or in current drug use;subjects who donated blood or received blood sampling in clinical trial within 3 months; subjects who had severe disease (including critical illness, infectious disease, food and drug allergy); subjects who had drug allergy history or with allergic constitution;subjects who had medical history of heart, liver, kidney, digestive tract or nervous and mental system;subjects with positive infection indices; pregnant, breastfeeding and menstrual women, or women planning pregnancy within 3 months; subjects with gastrointestinal disease or received gastrointestinal operation which may influence the drug absorption; subjects who had bad compliance by investigator's judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine test;urine routine test;stool routine test;blood biochemistry test;ECG test;pregnancy test;demography information;vital signs;Tmax;Cmax;AUC;t1/2;CL;MRT;Vd;Ke; | — |
Countries
China
Contacts
Public ContactRui Gao
Outcome results
None listed