Bioequivalence of of two oral contraceptive drugs containing ethinylestradiol and drospirenone in healthy female volunteers

Authors

  • Dr.Eduardo Abib Junior

Keywords:

Bioequivalence, Ethinylestradiol, Drospirenone, Contraceptive drugs

Abstract

The bioavailability and bioequivalence of two different film coated tablets containing ethinylestradiol and drospirenone 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 144 h (drospirenone). Ethinylestradiol and drospirenone 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 AUC0-t and Cmax values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals of ethinylestradiol were 89.13% #x2013; 95.32%, and 88.13% #x2013; 96.38%, respectively. The 90% confidence intervals of drospirenone were 94.50% #x2013; 102.12%, and 95.11% #x2013; 111.11%, respectively. Since the 90% confidence intervals for Cmax and AUC0-t were within the 80 #x2013; 125% interval proposed by Food and Drug Administration, it was concluded that the two ethinylestradiol and drospirenone formulations are bioequivalent in their rate and extent of absorption.

How to Cite

Dr.Eduardo Abib Junior. (2011). Bioequivalence of of two oral contraceptive drugs containing ethinylestradiol and drospirenone in healthy female volunteers. Global Journal of Medical Research, 11(3), 9–17. Retrieved from https://medicalresearchjournal.org/index.php/GJMR/article/view/112

Bioequivalence of of two oral contraceptive drugs containing ethinylestradiol and  drospirenone in healthy female volunteers

Published

2011-05-15