Research Article
Bioequivalence of Two Oral Contraceptive Drugs Containing Ethinylestradiol and Gestodene in Healthy Female Volunteers
Eduardo Abib Junior1,2*, Luciana Fernandes Duarte2, Moisés Luís Pirasol Vanunci2 and Melissa Lattaro Teixeira3
1Department of Clinical Medicine, Faculty of Medical Sciences, State University of Campinas (UNICAMP), 13083-970, Campinas, SP, Brazil, Tel: (19) 3521-7098
2Scentryphar Clinical Research, 13020-420, Campinas, SP, Brazil, Tel: (19) 3232-6350
3Sandoz do Brasil, 86183-600, Cambé, Pr, Brazil, Tel: (43) 3174-8000
- *Corresponding Author:
- Dr. Eduardo Abib Junior
Scentryphar Clinical Research
885, Barão de Itapura ave
Campinas, SP - Brazil. 13020-420
Tel: (19) 3232-6350
Fax: (19) 3231-6715
E-mail: [email protected]
Received Date: November 18, 2010; Accepted Date: January 04, 2011; Published Date: January 04, 2011
Citation: Junior EA, Duarte LF, Pirasol Vanunci ML, Teixeira ML (2010) Bioequivalence of Two Oral Contraceptive Drugs Containing Ethinylestradiol and Gestodene in Healthy Female Volunteers. J Bioequiv Availab 2:125-130. doi: 10.4172/jbb.1000044
Copyright: © 2010 Junior EA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
Abstract
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.
