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.
| Peer-reviewed Full Article 
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.
