Conclusion
Collectively, the assessment of pharmacokinetics demonstrated that the R
and T formulations were bioequivalent under fasting and fed conditions.
The 90% CIs for Cmax, AUC0-t and
AUC0-∞ were within the acceptable range for
bioequivalence (80.00-125.00%) as issued by the Pharmacopoeia of the
People’s Republic of China (ChP) guidelines. All subjects were well
tolerated for the two formulations of gefitinib, and there were no major
side effects. Thus, an alternative formulation of gefitinib would
provide an affordable, tolerable, and meaningful access to the drug for
cancer patients.