Chronic hepatitis C.
Conditions
Interventions
Test preparation and fasting group:sofosbuvir tablet administered once under fasting condition, 400 mg
Reference preparation and fasting group:sofosbuvir tablet (Gilead) administered once under fasting condition, 400 mg
Test preparation and fed group:sofosbuvir tablet administered once under fed condition, 400 mg
Reference preparation and fed group:sofosbuvir tablet (Gilead) administered once under fed condition, 400 mg
Sponsors
the Third Hospital of Changsha
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy subjects over the age of 18 years men and women.
Exclusion criteria
Exclusion criteria: 1. Have heart, liver, kidney, digestive tract, endocrine, blood system, respiratory system, nervous system and mental disorders and metabolic disorders and other medical history, or have a history of cancer; 2. Results of physical examination, electrocardiogram, laboratory projects and tests related to the study are abnormal and of clinical significance; 3. Had any surgery within three months before the screening; 4. A history of drug abuse during the past five years or those who used drugs within the first three months of screening; 5. Alcohol abuse history or moderate alcohol consumption in the past 2 years; 6. Take any prescription, over-the-counter, any vitamin product, nutraceutical, or herbal medicine within 14 days prior to taking the study medication; 7. Have taken any food or drink containing caffeine or xanthine, such as coffee, tea, chocolate, cola, etc. within 48 hours prior to taking the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Countries
China
Contacts
Public ContactXin Li
the Third Hospital of Changsha
Outcome results
None listed