Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single-Dose, Biperiodic, Double-Crossover Study.

Abstract

This study evaluated the safety, pharmacokinetic parameters, and bioequivalence (BE) of pomalidomide (POM) capsules (specification: 4mg) acquired from 2 sponsors (test [T] and reference [R]), under fasting and fed conditions. A single-center, randomized, open-label, 2-cycle, self-crossover, single-dose clinical trial was conducted. Subjects were divided into fasting (n=28) and fed (n=28) groups and assigned randomized treatment sequences (T-R or R-T). Blood samples for pharmacokinetic evaluation were collected within 48hours of administration, and safety was assessed throughout. Exposure to POM was similar following single-oral-dose administrations of T or R between the fasting and fed states. T and R exhibited BE, as demonstrated by statistical analysis; the 90%CIs of the geometric mean ratios of maximum plasma concentration, area under the plasma concentration-time curve (AUC)from time 0 to the last measurable concentration, and AUC from time 0 to infinity were within the acceptable BE range (80%-125%). Administering POM capsules with high-fat meals resulted in a 2.5-hour delay in time to maximum concentration and an ≈20.4% reduction in maximum plasma concentration. However, AUCs were comparable after dose administrations with and without food. The fast and fed groups revealed that POM capsules were tolerated in healthy Chinese male subjects, and so were orally bioavailable in healthy subjects under fasting and fed states.