Hetero Phrma (Beijing) Co., Limited

Primary study objective: To study the pharmacokinetics of the test preparation gefitinib tablets (specification: 250 mg, produced by HETERO LABS LIMITED) and the reference preparation gefitinib tablets (IRESSA®, specification: 0.25 g, produced by Kagamiishi Plant, Nipro Pharma Corporation) in healthy adult male subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objective: To evaluate the safety of the test preparation gefitinib tablets (specification: 250 mg) and the reference preparation gefitinib tablets (IRESSA®, specification: 0.25 g) in healthy adult male subjects.

Primary study objective: To study the pharmacokinetics of a single oral dose of the test preparation gefitinib tablets (250 mg, manufactured by HETERO LABS LIMITED) and the reference preparation gefitinib tablets (IRESSA®, 0.25 g, manufactured by Kagamiishi Plant, Nipro Pharma Corporation) in healthy adult male subjects, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary study objective: To evaluate the safety of the test preparation gefitinib tablets (250 mg) and the reference preparation gefitinib tablets (IRESSA®, 0.25 g) in healthy adult male subjects.