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%.

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