viral infection
Conditions
Interventions
A-Single-Dose Phase:This was a single-dose, open-label, randomized, 3-sequence, crossover study. In accordance with the randomization scheme, subjects were assigned to receive a single 0.2, 0.4 and 0.
B-Multiple-Dose Phase:Followed single-dose phase , volunteers assigned to continued into the multiple-dose phase, during which they were received the 0.2 g dose three times daily for 7 consecutive day
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
22 Years to 27 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of both sexes were eligible; 18 to 35 years of age, BMI 19 to 24 kg/m2; 2. All participants were in good health according to medical history, physical examination, 12-lead ECG, blood pressure and pulse rate and clinical laboratory measurements (i.e., hematology, blood biochemistry, hepatic function, a positive test for hepatitis B virus, and urinalysis); 3. Subjects were excluded if they were smokers, tobacco users or taking any medication (including over the counter medication) within 14 days prior to dosing, or caffeine-containing beverages were consumed within 72 h predose; 4. Each subject was informed about the nature and risk associated with the study, and has signed an informed consent form before participating.
Exclusion criteria
Exclusion criteria: 1. Volunteers who cannot meet the inclusion criteria; 2. Volunteers who were smokers, alcohol abuse or taking any medication; 3. The history of using drug which can damage main organs in the past 3 months; 4. Had known or suspected hypersensitive to the study drug; 5. With any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other systems; 6. Blood donation 90 days prior to the commencement of the study; 7. Investigator think the subject too poor in compliance to complete the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-8);AUC(0-t);Cma;AUC(0-infinite); | — |
Countries
China
Contacts
Public ContactLimei Zhao
Shengjing Hospital of China Medical University
Outcome results
None listed