生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence of Two Oral Contraceptive Drugs Containing Ethinylestradiol and Gestodene in Healthy Female Volunteers

Eduardo Abib Junior, Luciana Fernandes Duarte, Moisés Luís Pirasol Vanunci and Melissa Lattaro Teixeira

The bioavailability and bioequivalence of two different film coated tablets containing ethinylestradiol and gestodene were investigated in 36 healthy female volunteers after oral single-dose administration. The study was performed according to a single-center, randomized, single-dose, 2-way cross-over design with a wash-out phase of 28 days. Blood samples for pharmacokinetic profiling were taken post- dose up to 72 h (ethinylestradiol) and 96 h (gestodene). Ethinylestradiol and gestodene plasma concentrations were determined with a validated LC-MS/MS method. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% I.C) for the ratio of AUC 0-t and C max values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals of ethinylestradiol were 98.49% – 109.19%, and 100.62% – 111.69%, respectively. The 90% confidence intervals of gestodene were 94.07% – 105.91%, and 110.19% – 124.73%, respectively. Since the 90% confidence intervals for C max and AUC 0-t were within the 80 – 125% interval proposed by Food and Drug Administration, it was concluded that the two ethinylestradiol and gestodene formulations are bioequivalent in their rate and extent of absorption.