Bioequivalence Study of Palbociclib Tablets in Healthy Volunteers

This publication reports a bioequivalence study of test and reference palbociclib tablet formulations in 68 healthy volunteers, evaluated separately under fasting and fed conditions using a randomized crossover design. Plasma palbociclib concentrations were measured by HPLC-MS, and pharmacokinetic parameters were calculated by non-compartmental analysis using Phoenix WinNonlin, with bioequivalence assessed via WinNonlin's dedicated bioequivalence module. Geometric mean ratios for Cmax, AUC0-t, and AUC0-inf fell within the standard 80-125% range under both fasting and fed conditions, and adverse event rates were similar between groups. The results confirm that the test and reference palbociclib formulations are bioequivalent and comparably well tolerated regardless of food intake.