Healthy Volunteers
Conditions
Interventions
group1:0.5mg
group2:1mg
Sponsors
People's Hospital Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese Adult Subjects, evenly divided between men and women; 2. Aged 18 ~ 45 years old, with a group of subjects no younger than 10 years of age; 3. weight>/=50kg, Body mass index (BMI) in the context of 19-24kg/m2, [BMI= weight (kg)/height (m2)]; 4. With no history of allergy to drugs or any other substances; 5. With no history of Hematophobia and Needlesickness; 6. Medical history, physical examination, clinical examination, 12-lead ECG and X-ray was normal; 7. With no history of disease of the heart, liver, kidney and gastrointestinal disease, history of metabolic disease, neurological diseases; 8. Without taking drugs nearly four weeks; 9. Non-smoking and alcohol addiction; 10. Without abdominalpaindiarrhea nearly three weeks; 11. contraception during and nearly three months; 12. Willing and able to comply with the protocol and attend all study visits. Provide written informed consent prior to the initiation of any study-related procedures.
Exclusion criteria
Exclusion criteria: 1. People with primary disease of the heart, liver, kidney and other vital organs, history of gastrointestinal disease, history of metabolic disease, neurological diseases; 2. to be with history of eczema, psoriasis; 3. non-drug abuser; 4. hypotensive therapy; 5. history of orthostatic hypotension; 6. with of abnormal IgE; 7. history of asthma within 5 years; 8. took more than 5 cigarettes every day; 9. Subjects who more than 28 Units of alcohol every week (1 unit = 285mL beer or 20mL alcohol content or 1 cup wine), or took alcohol during and within 48h this study, or Test positive for alcohol within 24h this study; 10. Donated blood within 3 months (1unit=350ml), and Participated in clinical trials after 60 days If Donated blood<200ml; 11. Subjects who took any medication with known damaging effects on main organs within three months prior to this study; 12. Participated in other clinical trials within three months; 13. Subjects with clinically significant abnormalities; 14. Positive for HBsAg, HCVAb test; 15. Positive for HIVAb or syphilis test; 16. Positive for HCG(Blood or urine); 17. pregnant or breast-feeding women; 18. Not able to comply with the protocol and attend all study visits; 19. Unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCtn;Cmax;Tmax;t1/2;Vz/F; | — |
Countries
China
Contacts
Public ContactFang Yi
Sinopharm A-THINK Pharmaceutical Co.,Ltd.
Outcome results
None listed