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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 fasting 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib Tablet 250mg of Hunan Kelun | Experimental | During the study session, healthy subjects were orally administered a single dose of Gefitinib Tablet 250mg of Hunan Kelun under fasting conditions. |
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| Iressa® Tablet 250mg of AZN | Active Comparator | During the study session, healthy subjects were orally administered a single dose of Iressa® Tablet 250mg of AZN under fasting conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib Tablet 250mg of Hunan Kelun | Drug | Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter:Cmax | Peak Plasma Concentration (Cmax) | before drug delivery through 216 hours after dosing |
| Pharmacokinetic parameter:AUC | Area under the plasma concentration versus time curve (AUC) | before drug delivery through 216 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Iressa® Tablet 250mg of AZN | Drug | Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast. |
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