health subjects
Conditions
Interventions
donafenib (producted by Zelgen):1 tablet of IP taken per period, total 2 periods
donafenib (producted by WuXi AppTec):1 tablet of IP taken per period, total 2 periods
Sponsors
Jilin University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects willing to provide written informed consent and fully understand the study content, study procedures and potential adverse event; 2. Subjects willing to follow the protocol requirements; 3. Subjects(partners included) willing to have no pregnancy plan from screening to the next 6 months after the last dosing and take effective birth control measures listed in the appendix; 4. Female and Male subjects aged between 18 to 50 years (both inclusive); 5. Male subjects weighing not less than 50 kg, female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index in the range of 18-28 (including the boundary value); 6. Subjects having normal or no clinical significant physical examination and vital signs.
Exclusion criteria
Exclusion criteria: 1. Daily smoking more than 5 cigarettes during past 3 months; 2. Hypersensitivity to investigate products or with allergic constitution(Hypersensitivity to several kind of drug or food); 3. History or presence of drug abuse or alcoholism(taking 14 units of alcohol per week: 1 unit is equal to 285 mL of beer,or 25 mL of spirits, or 100 ml of wine); 4. History of blood donating or blood loss within 3 months prior to screening(more than 450mL); 5. Difficulty in swallowing solids like tablets/capsules or history of gastrointestinal diseases affecting drug absorption; 6. History of allergic dermatitis or other skin disease; 7. Subjects with coagulation disorder,hemorrhagic tendency(eg.recurrent gingival bleeding), increased risk of bleeding in 6 months, history of intracranial hemorrhage, gastrointestinal bleeding,purpura,history of major surgery in 30 days, history of active pathological bleeding, or intracranial hemorrhage; 8. Take any medication affecting the activity of hepatic enzyme during last 28 days prior to screening; 9. Take any prescribed medication,OTC medication,vitamins and herbal remedies during last 14 days prior to screening; 10. History of taking a special diet(including dragon fruits ,mangos,grapefruit ,etc) or strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion; 11. Consumption of inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 12) Subjects who have great changes on diet and exercise recently; 13. Subjects cannot accept the standard diet (including 2 eggs 100g,20g bacon,1 piece of bread 70g,115g potato chips,240ml milk); 14. Presence of significant ECG; 15. Female subjects in lactation period or have positive serum pregnancy test during the screening period or during the test; 16. Presence of significant laboratory examination or diseases (including but not limited to the gastrointestinal, renal,hepatic,neurological, hematic, endocrine, tumor, respiratory, immune, psychiatric or cardiovascular disease); 17. Positive screening test for any one or more: Hepatitis B, Hepatitis C,HIV,RPR; 18. Presence of illness or concomitant medication from screening to dosing; 19. Consumption of chocolate,caffeine/xanthine-containing products within 48 hours prior to dosing; 20. Consumption of alcoholic products within 48 hours prior to dosing; 21. Positive screening test for urine drug or history for drug abuse and consumption of narcotics past 5 years; 22. Other factors that investigator consider not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t?;?z;Vd/F;CL/F; | — |
Countries
China
Contacts
Public ContactZhang Guocheng
Jilin University First Hospital
Outcome results
None listed