Carlos Sverdloff, Clinical Operations Office, ATCGen Clinical Trials, SP, Campinas, Brazil
Vinícius Marcondes-Rezende, Clinical Operations Office, ATCGen Clinical Trials, SP, Campinas, Brazil
Ligia de Cassia-Val, Medical Affairs, Clinical Projects Management, Eurofarma Laboratórios S.A., SP, Itapevi, Brazil
Ma. Elena Cedano-Limón, Bioequivalence Operations, Scientific Office, Avant Santé Research Center S.A. de C.V., N.L., San Pedro Garza García, Mexico
Lygia Nerath-Bonanato, Medical Affairs, Clinical Projects Management, Eurofarma Laboratórios S.A., SP, Itapevi, Brazil
Murali Pendela, Bioequivalence Operations, Scientific Office, Avant Santé Research Center S.A. de C.V., N.L., San Pedro Garza García, Mexico
Mohammad H. Badii, Bioequivalence Operations, Scientific Office, Avant Santé Research Center S.A. de C.V., N.L., San Pedro Garza García, Mexico
Sreekanth Kakarla, Bioequivalence Operations, Scientific Office, Avant Santé Research Center S.A. de C.V., N.L., San Pedro Garza García, Mexico
Nelly C. Lemus-Castro, Bioequivalence Operations, Scientific Office, Avant Santé Research Center S.A. de C.V., N.L., San Pedro Garza García, Mexico
Background: Lenalidomide, derived from thalidomide, is vital for treating multiple myeloma and other blood cancers due to its immunomodulatory and anti-angiogenic effects. Ensuring bioequivalence between generic and branded forms is crucial, especially for public health affordability. Objective: To evaluate pharmaceutical bioequivalence between two formulations of 25 mg lenalidomide capsules in healthy male subjects under fasting conditions. Method: Conducted as an open label, monocentric, randomized, 2 x 2 crossover trial with 32 participants in fasting state, analyte concentrations were measured using UPLC-MS/MS, and then the pharmacokinetic parameters were determined. Results: Statistical analysis has determined the geometric mean ratio (90% CI) of the test drug/reference drug for lenalidomide were 90.03 to 114.13% for Cmax and 88.21 to 101.02% for AUC0-t. Power of the test was 92.8% for Cmax and 100.0% for AUC0-t. Conclusion: Both formulations are bioequivalent and, therefore, they are interchangeable, according to the Brazilian criteria, since confidence intervals for Cmax and AUC0-t ratios were within 80 and 125%.
Keywords: Lenalidomide. Bioequivalence. Capsules. Liquid chromatography-tandem mass spectrometry. Immune modulator. Antineoplastic.
