Locally advanced or metastatic non-small cell lung cancer (NSCLC) [Only non-drug-resistant rare epidermal growth factor receptor (EGFR) mutations, including L861Q, G719X and/or S768I]
Conditions
Interventions
A sequence group:On the first day, a single dose of sutetinib maleate capsules 100 mg was taken on an empty stomach, and pharmacokinetic plasma samples were collected from 0 to 72 hours (h). On the ei
B sequence group:On the first day, a single dose of sutetinib maleate capsules 100 mg was taken after a meal, and pharmacokinetic plasma samples were collected from 0 to 72 hours. On the eighth day, a
Sponsors
The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18 to 55 (including cut-off value), no gender limits. 2. The body mass index ranges from 19 to 28 kg/m^2 (not including the upper limit of 28), and the weight of men is 50 kg and above, and the weight of women is 45 kg and above. 3. Subjects who agree to abstain from sex or take effective non-drug contraceptive measures for at least 6 months from the screening to the last study drug administration (for female subjects, it is also required to start abstinence or take effective non-drug contraceptive measures 2 weeks before entering the study). 4. No history of major diseases, and physical examination, vital signs, 12-lead electrocardiogram (ECG), frontal chest radiograph, abdominal B-ultrasound (both kidneys) and laboratory examinations (including blood routine, urine routine, the results of blood biochemistry, coagulation function) are normal, or although they are outside the range of normal reference values, they have no clinical significance as judged by the researcher. 5. Be able to communicate with clinical staff, fully understand the purpose of this trial and be able to comply with the requirements of this research, and sign on the signed informed consent form to indicate willingness to participate in this research.
Exclusion criteria
Exclusion criteria: 1. There are any medical conditions (such as cardiovascular, liver, kidney, digestive tract, immune blood, endocrine, metabolism,nervous, mental diseases, etc.), especially a history of dysphagia, peptic ulcers or any gastrointestinal diseases affecting drug absorption. 2. Hepatitis B surface antigen positive, hepatitis C antibody positive, human immunodeficiency virus (HIV) antibody positive, and syphilis antibody positive. 3. Received major surgery (judged by the investigator based on the subjects medical history) or suffered excessive trauma within 6 months before taking the study drug, or planned to undergo surgery during the study period. 4. Allergies, if known to have a history of allergies to two or more substances; or may be allergic to the active ingredients of the test drug or its excipients as judged by the investigator. 5. Participated in any drug or medical device clinical trial within 3 months before enrollment. 6. Blood donation or blood loss> 400 mL within 3 months before enrollment. 7. Drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits with 40% alcohol content or 150 mL wine with 12% alcohol content) in the 6 months before enrollment; or smoking more than 5 cigarettes per day within 3 months before enrollment; or smoking and alcohol can not be banned within 48 hours before administration. 8. Excessive drinking of strong tea, coffee or caffeine-containing beverages every day (8 cups or more per day, 1 cup=250 mL) for the 3 months before enrollment; or the post-metabolic production cannot be prohibited within 48 hours before administration caffeine or xanthine-containing foods or beverages (such as coffee, strong tea, chocolate, cola, etc.), strenuous exercise; or failure to follow a uniform diet. 9. Use soft drugs (such as marijuana, ecstasy, KEN powder, Magu, etc.) within 3 months before enrollment or use hard drugs (such as cocaine, heroin, methamphetamine, etc.) within 1 year before screening. 10. A urine drug test is positive, or an alcohol breath test is positive. 11. Any medicines, including Chinese herbal medicine, vaccines, vitamins, dietary supplements, etc., have been used within 1 month or 5 half-lives (whichever is longer) before enrollment. 12. Foods containing strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzyme CYP3A4, such as grapefruit, dragon fruit, mango, grapes or juice containing the above-mentioned fruit components have been used within 1 month before enrollment Wait. 13. Difficulty in venous blood collection, inability to tolerate venipuncture, or history of fainting needles and bleeding. 14. Acute illness occurred before the study drug was taken, for example, diarrhea occurred within 24 hours before the study drug was taken for the first time. 15. The investigator believes that the subject has any other factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tmax;Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactLi Juan
Jiangbei International District, Nanjing Gulou Hospital, Pukou District, Nanjing City, Jiangsu Province
Outcome results
None listed