Epidermal growth factor receptor (EGFR) exon 19 deletion mutation or exon 21 L858R substitution mutation locally advanced or metastatic non-small cell lung cancer (NSCLC)
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gender: male and female healthy subjects, and the selected subjects should have appropriate gender ratio; 2. Age: 18-45 years old (including critical value) healthy subjects; 3. Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass index [BMI = weight (kg) / height 2 (M2)] in the range of 19.0-26.0kg/m2 (including the critical value); 4. The subjects must give informed consent to the study before the trial and sign the written informed consent voluntarily; 5. The subjects can communicate well with the researchers and complete the research according to the research regulations.
Exclusion criteria
Exclusion criteria: Those who have one of the following conditions can not be included in this test: 1. Subjects allergic to any component of dacotinib tablets and its related compounds and excipients, or persons allergic to two or more drugs (or food); 2. Those who can't follow the same diet (such as intolerance to standard food, etc.); 3. Those who can't tolerate venipuncture and have a history of needle and blood sickness; 4. Patients with clinically significant skin, cardiovascular, liver, kidney, endocrine, digestive system, blood system, respiratory system, infection, malignant tumor, mental system, nervous system and other major medical history or existing above diseases judged by researchers; 5. Patients who had undergone major surgery within 6 months before screening, or planned to undergo surgery during the study period, and those who had undergone surgery that would affect drug absorption, distribution, metabolism and excretion (except appendicitis surgery); 6. Physical examination, vital signs measurement, ECG examination, chest CT examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, etc.) in screening period, and patients with abnormal clinical significance judged by researchers; 7. Patients with abnormal nasal mucosa or conjunctivitis or oral mucositis or paronychia found in screening physical examination; 8. Patients with abnormal results of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or HIV antibody with clinical significance; 9. Patients who had consumed too much tea, coffee or caffeinated drinks (more than 8 cups per day, 1 cup = 200ml) for a long time (within 3 months before screening); or those who had consumed any caffeinated food or drink (such as coffee, strong tea, chocolate, etc.) within 48 hours before enrollment; 10. Patients who have taken any drink or food rich in xanthine or grapefruit or other factors affecting drug absorption, distribution, metabolism and excretion within 48 hours before entering the group; 11. Patients who have used any drug that interacts with dacotinib tablets in the first 4 weeks of screening (such as rabeprazole, CYP2D6 substrate dextromethorphan, etc.); 12. Patients who used long-acting estrogen or progesterone injection or implant within 6 months before the trial; patients who used short acting contraceptives within 30 days before the trial; patients who used long-acting estrogen or progesterone injection or implant within 6 months before the trial; 13. Patients who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products within 14 days before screening; 14. The patients who smoked more than 5 cigarettes per day in the first 3 months, or who had positive nicotine test (urine nicotine test) before enrollment, or who could not accept no smoking during the whole trial period after enrollment; 15. Study the patients with positive results of alcohol breath test before the first medication (more than 0.0mg/100ml), or drink more than 14 standard units per week within 6 months before screening (1 standard unit contains 14g alcohol, such as 360ml beer or 45ml spirits with 40% alcohol or 150ml wine); 16. Patients with a history of drug abuse (such as morphine, methamphetamine, ketamine, dimethylene dioxoamphetamine, tetrahydrocannabinolic acid, cocaine, etc.) within one year before the trial or those with positive drug screening before the first drug use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed