Bioequivalence study between two formulations of 10mg lenalidomide capsules in healthy male subjects under fasting conditions

Abstract

OBJECTIVE: To evaluate pharmaceutical bioequivalence between two formulations of 10mg lenalidomide capsules in healthy male subjects under fasting conditions. MATERIAL AND METHODS: An open label, monocentric, randomized, 2x2 crossover study in 32 healthy men under fasting conditions comparing two formulations of lenalidomide capsules. Analyte concentrations in human plasma were determined using a validated liquid chromatography with a tandem mass spectrometer detector method (UPLC-MS/MS). RESULTS: Statistical analysis has determined geometric mean of test/reference ratio, confidence intervals, and power of the test to the pharmacokinetic parameters Cmax and AUC0-t as required by Anvisa resolution, the geometric mean ratio (90%CI) of the test drug/reference drug were 84.01 to 108.10 for Cmax and 98.58 to 105.34 for AUC0-t. Power of the test was 89.9% for Cmax and 100.0% for AUC0-t.

Keywords

• lenalidomide
• therapeutic equivalency
• antineoplastic agents