Bioequivalence of of two oral contraceptive drugs containing ethinylestradiol and drospirenone in healthy female volunteers
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.
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2011-05-15
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