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
Group A on an empty stomach:TR
Group B on an empty stomach:RT
Group C on an empty stomach:TR
Group D on an empty stomach:RT
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Gender: male and female healthy subjects, and the selected subjects should have appropriate gender ratio; 2.Aged 18 to 45 years (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 (m^2)] in the range of 19.0-26.0kg/m^2 (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: 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.Patients can't follow the same diet (such as intolerance to standard food, etc.); 3.Patients 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 proton pump inhibitor 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; 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.Drinking more than 14 standard units per week (1 standard unit containing 14g alcohol, such as 360mL beer or 45mL 40% alcohol spirits or 150mL wine) in the 6 months prior to screening, or positive breath test for alcohol (greater than 0.0mg/ 100mL) prior to study initial administration; 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 in the study; 17.Pregnant or lactating women, as well as male subjects (or their partners) or female subjects with pregnancy plans or sperm and egg donation plans during the whole trial p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum blood concentration;Area under the blood drug concentration-time curve from 0 to the last time point T;Area under the blood drug concentration-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed