Bioequivalence trial between two escitalopram oxalate 20mg coated tablet formulations

Abstract

Objective. To evaluate the bioequivalence between 20 mg escitalopram oxalate Eurofarma vs Lexapro^® coated tablets in healthy subjects under fast conditions. Method. An open label, monocentric, randomized, 2x2 crossover study in 36 healthy adults under fasting conditions comparing two formulations of escitalopram coated tablets. Analyte concentrations in human plasma were determined using a validated liquid chromatography with a tandem mass spectrometer detector method (LC-MS/MS). Results. Statistical analysis has determined geometric mean of test/reference ratio, confidence intervals, coefficient of variation intra-subject and power of the test to the pharmacokinetic parameters C_max, AUC_0-t, and AUC_0-∞. The geometric mean ratio (90%CI) of the test drug/reference drug for escitalopram were 94.626 to 104.087% for C_max, 92.006% to 97.992% for AUC_0-t, and 89.949% to 96.600% for AUC_0-∞. Power of the test was 100% for all parameters and intra CV were 10.035% for C_max, 6.628% for AUC_0-t, and 7.504% for AUC_0-∞. Conclusion. Both formulations are bioequivalent and, therefore, they are interchangeable, according to the Brazilian criteria, since confidence intervals for C_max and AUC_0-t ratios were within 80% and 125%, according to Anvisa resolution RE nº 1170/2006.