Bioequivalence Study of Gefitinib Tablets Under Fed Conditions
Bioequivalence Study of Gefitinib Tablets Under Fed Conditions
The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence
 Study. During each session, the subjects will be administered a single dose of 250mg
 Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of
 AstraZeneca) under fed conditions.
An Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study . During each
 session, the subjects were randomly assigned in a 1:1 ratio to receive a single 250-mg dose
 of either the test formulation(Hunam Kelun) or the reference formulation(Iressa®
 Astrazeneca), and vice versa, with a 21-day washout period between administration periods.
Inclusion Criteria:

 1. Healthy male subjects.

 2. At least 18 years of age .

 3. Weight at least 50kg and body mass index between 19 and 26 kg/m2.

 4. Informed consent and voluntary to sign a written informed consent.

 5. Can communicate with researchers and complete the study in accordance with the
 provisions of the research.

 Exclusion Criteria:

 1. Abnormal diagnostic findings, and clinical significances determined by researchers
 (physical examination,vital sign, ECG,X-ray,blood routine examination, urine routine
 examination,blood biochemical examination and coagulation test).

 2. Having functional gastrointestinal disease or inadequate secretion of gastric acid or
 is treated for a acid suppression. Which including gastro upset, dyspepsia, gastritis,
 gastric ulcer, duodenal ulcer, gastric secrete melanoma, etc.

 3. Taking drugs that alter the environment of the gastrointestinal，especially alter the
 gastrointestinal pH，within 30 days before the first dose. Such as， Proton pump
 inhibitors：thiophene, omeprazole, lansoprazole, esomeprazole, etc .and H2 antagonist
 ranitidine：cimetidine, famotidine, etc .and antacids hydrogen carbonate Sodium,
 magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc .and gastric mucosal
 protective agent：sucralfate，and so on.

 4. Not comply with a unified diet( such as standard meal) or has swallowing difficulties.

 5. Allergic to any ingredient or excipients of the study drug.

 6. History of gastrointestinal disorders and severe liver and kidney diseases ，which
 affect the absorption or metabolism of drugs so far.

 7. History of ocular surface damaging diseases (such as corneal perforation, ulcers,
 etc.).

 8. History of serious blood diseases.

 9. With skin, cardiovascular, liver, kidney, digestive, neurological, psychiatric,
 metabolic disorders, or any other disease that can interfere with the results of the
 trial.

 10. History of long-term excessive drinking (more than 8 cups a day, 1 cup = 250 mL) of
 tea, coffee or caffeinated beverages，or 48 hours before the first dose intake of any
 food or drink containing caffeine (such as coffee, tea, chocolate, etc.).

 11. Ingested any drinks or foods that are rich in xanthine and grapefruit or affect the
 drug absorption, distribution, metabolism and excretion.

 12. A positive result in breath alcohol test or previous alcohol abuse (ie, men drink more
 than 28 standard units a week [1 standard unit defined as containing 14 grams of
 alcohol, such as would be found in a standard shot of hard liquor, a 12-ounce bottle
 of beer, or a 5-ounce glass of wine] Or regular drinking(more than 14 standard units
 of alcohol per week) within 6 months before the trial.

 13. Daily intake of more than 3 cigarettes from 3 months before the study to 48 hours
 before the first dose or intake of tobacco or any type of tobacco product within 48
 hours before the first dose.

 14. Taking drugs that interact with gefitinib （such as CYP3A4 inhibitors： itraconazole,
 ketoconazole, clotrimazole, Ritonovir, etc .and CYP3A4/5 inducers：rifampicin,
 carbamazepine, phenobarbital, phenytoin, dexamethasone, etc .and CYP2D6
 inhibitors：Fluoxetine, paroxetine , etc .） within 30 days before the first dose. And
 use of any prescription drugs, non-prescription drugs, Chinese herbal medicine, health
 products within 14 days before the first dose.

 15. Volunteer in any other clinical drug study or taking any clinical trial drug within 3
 months prior to this study.

 16. Blood donation or lost more than 450mL blood within 3 months prior to the study，or has
 a plan to donate blood or blood components within the study period or within 3 months
 after the end of study.

 17. Suffering from a serious illness or having undergone major surgical procedures within
 1 years before the firs dose.

 18. Abnormal blood coagulation, or having a known tendency of severe bleeding..

 19. A positive result in drug test or existing drug abuse (eg, morphine, marijuana,
 methamphetamine, dimethylene bisoxamine amphetamines, ketamine, etc.) within 1 year
 prior to the trial.

 20. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)
 antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.

 21. Having fertility planning or reluctant to take appropriate contraceptive during the
 study or within 6 months after the study.

 22. Other unfavorable factors diagnosed by investigators.