None listed
Conditions
Interventions
fasting T-R group:The selected subjects entered the Phase I ward 1 day before the first cycle of the test, and the subjects fasted for at least 10 hours ning of the administration day, the test prepar
fasting R-T group:The selected subjects entered the Phase I ward 1 day before the first cycle of the test, and the subjects fasted for at least 10 hours overnight before taking the drug. After a blank
Sponsors
Shanghai Pudong New Area People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gender: adult male or female healthy subjects; 2) Age: = 18 years old; 3) Weight: male subjects shall not be less than 50.0kg, female subjects shall not be less than 45.0kg, and body mass index [BMI=weight (kg)/height 2 (m2)] shall be within the range of 19.0~26.0kg/m2 (including boundary value); 4) Good communication with researchers; 5) Subjects must give informed consent to the test before the test and voluntarily sign a written informed consent form. Those who do not meet one of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: 1) The results of physical examination, vital signs, blood routine test, blood biochemistry, urine routine test, blood coagulation function, full chest radiograph and 12 lead ECG are abnormal and of clinical significance; 2) Virology examination (including hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, Treponema pallidum antibody) results are positive; 3) Urine drugs (morphine, tetrahydrocannabinoid acid, methamphetamine, dimethylenedioxymethamphetamine, ketamine) with positive screening results; 4) People with chronic or serious disease history of liver, kidney, endocrine, urinary system, digestive system (especially history of peptic ulcer), blood and lymphatic system, respiratory system, cardiovascular system, nervous system (history of multiple headache), mental disease or existing diseases of the above systems; 5) Have a history of drug abuse and drug dependence; 6) People who have ever suffered from ocular surface damage diseases (such as corneal perforation, keratitis, ulcerative keratitis or severe dry eye) or need to wear contact lenses; 7) Those who have undergone surgery within 3 months before screening, or planned to undergo surgery during the study or within 2 weeks after the completion of the study; 8) Those who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbal medicine) or health products within 30 days before screening; 9) Allergy: people who have been allergic to alfatinib or other tinic drugs in the past; Two or more allergies to other drugs, food and environment; Or those who are prone to skin rash, urticaria and other allergic symptoms; 10) Smokers in 3 months before screening (defined as: average daily smoking = 5 cigarettes in 3 months before screening); 11) Alcohol breath test result is positive or excessive drinking within 6 months before screening (that is, drinking more than 14 standard units every week, one alcohol unit is equal to 10 mL or 8 g pure alcohol, 25 mL 40% Baijiu, 330 mL 5% beer, and 175 mL 12% red wine are about 1.0, 1.5, and 2.0 alcohol units respectively); 12) Those who drink too much tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup=250mL) within 6 months before screening; Or those who ingest any food or drink rich in caffeine and/or purine (such as coffee, strong tea, chocolate and caffeinated carbonated drinks, cola, etc.) within 48 hours before the first administration of the study; 13) Those who have taken drinks or foods rich in grapefruit for a long time in the past; Or those who have taken any drink or food rich in grapefruit within 48 hours before the first administration of the study; 14) Those who cannot tolerate venipuncture, or have a history of needle and blood sickness; 15) Those who have special requirements for diet and cannot accept a unified diet or have difficulty swallowing; 16) Anorexia, dieting at ordinary times or having started a significantly abnormal diet (such as dieting and low sodium) within 4 weeks before screening; 17) Those who have participated in other clinical trials within 3 months before screening; 18) Those who have donated or lost 450 mL or more of blood within 3 months before screening or who plan to donate blood or blood components during the study period; 19) Female subjects with positive pregnancy test or in lactation period; 20) Male subjects (or their partners) or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of Afatinib maleate in the blood plasma; | — |
Countries
China
Contacts
Public ContactMa Jun
Shanghai Pudong New Area People’s Hospital
Outcome results
None listed