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Conditions
Interventions
Sponsors
The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, 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 19-26kg/m2. 3. subjects in healthy condition, without significant clinical symptoms or abnormal laborary test results of clinical significance. 4. agreed to continue to take effective contraceptive measures during the study period and within 6 months after the last study drug administration, and there is no plan to donate sperm and eggs (oocytes, oocytes). 5. 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. 6. subjects have a fair understanding of the purpose, property, progress and adverse event that may happen, and volunteer to sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Subject allergic to the study drug or its ingredients; subject has history of allergy or belongs to allergic constitution; 2. 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; 3. subject had took drug that inhibits or induces liver metabolism in the past 3 months. (eg, inducerbarbital, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitorSSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) 4. those with a history of blood donation or acute blood loss in the first 3 months (400 mL) or who intend to donate blood within the research period; 5. Take any prescription or over-the-counter medication14 days prior to the planned first study drug administration. (including vitamins and botanical supplements such as St. John's wort (St. John's Wort)) Oral contraceptives, paracetamol (acetaminophen) and persistent use of hormones (except for intrauterine devices); 6. had participated in other drug clinical trials within the first 3 months; 7. At this stage or once addictted drug or alcohol, or cannot quit smoking during the study; subject drank frequently in the past 3 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); 8. Any long-term overdose (more than 8 cups a day, 1 cup = 200 mL) tea, coffee or caffeinated beverages; subject refuses to stop any food or revee with methylxanthine, such as caffeine (coffee, tea, coke, choclate)from 2 days before to the end of the study; 9. subject took over 10 cigarettes every day in the past 3 months. 10. Those who have positive alcohol breath test or positive drug abuse screening; 11. One of HbsAg, HCV antibody, HIV antibody, syphilis turn out to be positive; 12. Female subjects have been pregnant, breast-feeding, or plan to become pregnant during the study period or within 6 months after the last dose; 13. Surgery within 4 weeks prior to the trial, plans to perform surgery that may interfere with the results of this study Surgery or operation; 14. Can not swallow solid oral preparations with water; 15. Intolerant venipuncture; 16. Subject insuitable to the study according to researchers. 17. Lactose intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Cmax; | — |
Countries
China
Contacts
Public ContactWu Guolan
The First Affiliated Hospital, Zhejiang University
Outcome results
None listed