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.