None listed
Conditions
Interventions
Two phases:investigational product
Sponsors
Xiyuan Hospital, CACMS
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 18-50 years (including 18 and 50); 2. Males and females; 3. At least 50kg weight for men and 45kg for women, BMI between 19-26 kg/m2(including 19 and 26); 4. Subject who receive the informed consent and volunteer to sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1.People who have allergic constitution or allergic history,especially are allergic to the product, excipients and analogues; 2. People with dysphagia or any gastrointestinal disease history which may affect the drug absorption; 3. People with history of any serious disease, i.e. cardiovascular disease, endocrine system disease, pulmonary disease, hematologic diseases, immune system disease and metabolic disorder; 4. People with neurological,psychiatric,or language disorders, who are unable to communicate or cooperate with medical staff; 5. People who have difficulty in blood sampling, or with the history of acupuncture syncope and blood phobia; 6. People who received the hormone replacement therapy (except for hormonal contraceptive drug) within three months prior to first dosing; 7. People who participated in any clinical study and took the investigational product in the past 3 months prior to first dosing; 8. People who smoke more than 5 cigarettes per day and can't quit smoking during the clinical trial; 9. Blood and blood components donation or blood loss exceeds 200mL in the past 3 months prior to first dosing, or during the clinical trial, or within 3 months after the trial; 10. Long-term drinking too much tea, coffee or caffeinated beverages (8 cups a day, 1 cup=200 ml); 11. People who used any known liver enzyme inducers,or liver enzyme inhibitors within 30 days prior to first dosing; 12. People who took any drug (including prescription drug, over-the-counter drug, Chinese herbal medicine, etc.) or health products within 14 days prior to first dosing; 13. People who drank or had food contain caffeine (i.e. tea, chocolate, coffee, etc.), or rich in xanthine (i.e. sardines, beef liver, yellow bean sprouts, etc.) or grapefruit ingredient (i.e. grapefruit juice, lemon juice, etc.) within 48 hours prior to first dosing; 14. People who can't accept the unified diet; 15. Pregnant or lactating woman, or those who plan for pregnancy during the clinical trial, and people who are not willing to use contraception from two weeks prior to first dosing to 1 month after the trial; 16. Clinically significant abnormal findings on physical examination, vital signs examination, laboratory evaluation, ECG, which may influence the evaluation result; 17. CCr<50mL/min; 18. Positive serum examination of HBsAg, anti-HCV, anti-HIV and TP; 19. Abnormal alcohol breath test (acceptable range: 0-3mg/100mL); 20. Alcoholism in the past 6 months prior to the study screening (with current alcoholism evidence, i.e. over 14 units of alcohol per week, 1 unit equals to 360mL beer or 45mL of alcohol content of 40% spirits or 150mL wine); 21. People who had history of drug abuse and drug dependence in the past one year prior to the study screening, or the positive urine test result; 22. People who are not suitable to participate in the study by the investigators judgement or for their own sake.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration; | — |
Countries
China
Contacts
Public ContactLi Rui, Gao Rui
Xiyuan Hospital, CACMS
Outcome results
None listed