lung cancer
Conditions
Interventions
Fasting T-R group:Subjects took the test preparation in the first cycle, and took the reference preparation in the second cycle
Fasting R-T group:Subjects took the reference preparation in the first cycle, and took the test preparation in the second cycle
Postprandial T-R group:In the postprandial state, the subjects took the test preparation in the first cycle and took the reference preparation in the second cycle
Postprandial R-T group:In the postprandial state, the subjects took the reference preparation in the first cycle and took the test preparation in the second cycle
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged 18 years or above; 2. Body mass index (BMI)=weight (kg)/height 2 (m2), with a body mass index within the range of 19.0 to 26.0 (including critical values), and a weight of no less than 50.0 kg; 3. The subjects have no family planning or sperm donation plan within one month from the start of the experiment to the last administration, and voluntarily take effective contraceptive measures; 4. Before the experiment, fully understand the content, process, and potential adverse reactions of the experiment, sign an informed consent form, voluntarily participate in the experiment, and be able to complete the study according to the requirements of the experimental protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals who have consumed an average of more than 14 units of alcohol per week (1 unit=285 mL of beer, 25 mL of spirits, or 150 mL of wine) or who have tested positive for alcohol breath test within the three months prior to administration; 2. Those who smoke an average of 5 cigarettes per day or have a positive cigarette test result within the first month before administration; 3. Drug abuse, drug dependence, or drug screening positive individuals; 4. Those who donate blood or experience significant blood loss (>400 mL) or participate in drug trials as subjects within 3 months before administration; 5. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day within the first month before administration; 6. Those who have suffered from chronic or basic diseases in the past or who have been clinically diagnosed with heart, respiratory, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, bone system, immune system, nervous system disease diseases or mental diseases/disorders; Or any disease that the researcher determines to have an impact on the results of this experiment and the safety of the subjects; 7. Those with a history of needle or blood sickness; 8. Known as lactose intolerance, lactase deficiency or glucose galactose malabsorption; 9. Individuals who are allergic to gefitinib or other components of this product, or have experienced allergies to two or more drugs or foods; 10. Those who cannot comply with the corresponding regulations of the Phase I Clinical Trial Research Center of the drug, or those who cannot tolerate the diet provided by the center; 11. Those who have used any drugs (such as inducers: phenobarbital, isopentabarbital, phenytoin sodium, carbamazepine, rifampicin, dexamethasone, St. John's wort, etc.) to inhibit or induce the activity of liver drug enzymes (CYP3A4 or CYP2D6) within 30 days before administration; inhibitors: fluoxetine, paroxetine, itraconazole, ketoconazole, fluconazole, verapamil, diltiazem, erythromycin, clarithromycin, etc; 12. Those who have used any medication, including over-the-counter drugs and traditional Chinese medicine, within 2 weeks before administration; 13. Those who are positive for HBsAg, HCV antibodies, HIV antibodies, and Treponema pallidum antibodies; 14. Those with abnormal vital signs, physical examination, blood biochemistry, routine hematuria, chest X-ray or ECG examination and clinical significance; 15. Take special diet (including grapefruit, and/or diet containing xanthine, such as coffee, tea or chocolate), or other drinks or foods that affect absorption, distribution, metabolism, excretion and other factors within 48 hours before administration; 16. The researcher has determined that the subject has any other factors that are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed