None listed
Conditions
Interventions
2:investigational product
Sponsors
Xiyuan Hospital, CACMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese healthy male and female (no less than 1/3) volunteers aged 18-50; 2. At least 50kg weight for men and 45kg for women, BMI between 19-26 kg/m2(including 19 and 26); 3. Subject who can understand and follow the study process and restrictions, volunteer to participate in clinical studies and provide written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. History of any clinically?significant cardiovascular, hepatic, pulmonary, renal, archenteric, endocrine, metabolic or hematologic diseases; 2. Clinically significant abnormal findings on physical examination, laboratory evaluation, ECG, chest X-ray or vital signs by investigators judgment; 3. Use of any prescription within 4 weeks or any over-the counter products, vitamins, herbal products within 2 weeks prior to first dosing; 4. Clinically significant abnormal findings of food, drug allergy, or allergy reaction by investigators judgment; 5. Alcoholism in the past one year prior to the study screening (with current alcoholism evidence, i.e. 2 drinks per day, 1 drink alcohol consumption equals to 150ml red wine, or 360ml beer or 50ml white wine), or breath alcohol test result is beyond the range of 5mg/100mL; 6. Drug abuse in the past one year prior to the study screening, or positive urine test result; 7. Smoking in the past 3 months prior to the study screening, and more than 5 cigarettes per day; 8. volunteers who participated in any clinical study in the past 3 months prior to first dosing; 9. Blood donation exceeds 400mL or 2 units in the past 3 months prior to first dosing; 10. Refuse to avoid smoking, alcohol, drinking caffeinated?beverages?within 24 hours prior to first dosing, or strenuous exercise, or other factors that affected absorption, attribution, metabolism and excretion; 11. Pregnant or lactating women, or subject with positive serum HCG pregnancy test, or dont follow the investigator s guidance to use acceptable forms to contraception; 12. Subject with positive serum examination (HBsAganti-HCVanti-HIVTP) in the screening periodu; 13. Volunteers who are not suitable to participate in the study by investigator's judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactLi Rui, Gao Rui
Xiyuan Hospita, CACMS
Outcome results
None listed