1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability of comparative studies which examine people in vivo pharmacokinetic behavior, provide the basis for clinical use. 2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese patients with locally advanced or metastatic non-small cell lung cancer.
Name: Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial
Description: Gefitinib Tab （CTTQ），First medication,250mg；Type: Drugtrial group
Name: Gefitinib tablets (Yi Ruisha），First medication
Description: Gefitinib tablets (Yi Ruisha），First medication,250mg；Type: Drugcontrol group
Name: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.
Description: From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）Type: Drugtrial group control group
Description: After the use of gefitinib to reach the highest plasma concentration
Measure: Gefitinib plasma concentration Time: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administrationDescription: Taking the time required for the concentration of gefitinib to reach the peak
Measure: Tmax time Time: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administrationDescription: The area between the axis of the coordinate and the time drug concentration curve
Measure: AUC0-t Time: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administrationDescription: The time required for gefitinib to decrease by half the highest concentration in plasma
Measure: t 1/2 Time: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administrationDescription: Gefitinib absorbs the relative amount of blood into the cycle
Measure: F Time: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administrationAllocation: Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: 1. Patients volunteered to participate in this study, signed informed consent; 2. ≥18 years old; ECOG PS score: 0 ~ 1; expected survival period of more than 3 months; 3. patients with locally advanced or metastatic non-small cell lung cancer diagnosed by histology or cytology, who can not receive radical surgery or radiotherapy; patients with measurable lesions(according to RECIST criteria); 4. Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performed by providing a detectable specimen (tissue or cancerous pleural effusion) prior to enrollment; 5. --- L858R ---