Introduction
Cancer is a primary public health concern throughout the world and its
occurrence significantly reduces people’s quality of life and leads to a
range of medical problems [1, 2]. Cancer treatment
has undergone tremendous changes, from previous chemotherapy and surgery
to current molecular targeted drug therapy, onco-immunology therapy and
combination therapy. Among them, the clinical practice of epidermal
growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) has
significantly improved the benefit-risk ratio of cancer patients.
Gefitinib, a first-generation EGFR-TKI, was authorized by the U.S. Food
and Drug Administration (FDA) in 2003 and launched in China for
treatment of non-small cell lung cancer (NSCLC) in February 2005. As the
latest reported literature shows, gefitinib alone or chemotherapy with
gefitinib plus pemetrexed may be cost-effective for patients with
advanced EGFR mutated NSCLC in China [3, 4].
Evaluating the bioequivalence or substitutability of the tested
formulation with the reference formulation will undoubtedly facilitate
the treatment and recovery of cancer patients. The purpose of this
open-label, randomized, two-period crossover, comparative
pharmacokinetic study is to explore the bioequivalence of gefitinib in
reference (R) or test (T) formulation in healthy Chinese subjects under
fasting and fed conditions.