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Bioavailability and bioequivalence of etonogestrel from two oral formulations of desogestrel: Cerazette and Liseta.
- Source :
-
European journal of drug metabolism and pharmacokinetics [Eur J Drug Metab Pharmacokinet] 1999 Oct-Dec; Vol. 24 (4), pp. 335-43. - Publication Year :
- 1999
-
Abstract
- In a three-period cross-over study with 24 healthy young females (study part 1), the bioavailability of etonogestrel (3-ketodesogestrel) was determined after a single oral dose of two Cerazette tablets (each containing 75 microg desogestrel), one Liseta tablet (containing 150 microg desogestrel and 1.5 mg 17beta-estradiol), and an intravenous dose of 150 microg etonogestrel. Etonogestrel serum levels from 23 subjects could be analysed by radio-immunoassay. The geometric mean bioavailability of etonogestrel from Cerazette and Liseta tablets was 0.79 and 0.82, with 95% confidence intervals of 0.73-0.86 and 0.76-0.88, respectively. Also, the oral formulations were found to be bioequivalent. Subsequently, the single-dose pharmacokinetic parameters of etonogestrel from Cerazette tablets were compared with those after multiple dosing of one Cerazette tablet once daily for 7 days, in a subgroup of 12 subjects (study part 2). A steady state was observed from the fourth day of daily dosing onwards, with time-invariant parameters except for a 14% lower dose-normalised AUC. The least-squares geometric means of the elimination half-life of etonogestrel were approximately 30 h for the three single-dose treatments in study part 1, as well as for the single- and multiple-dose treatments of Cerazette in study part 2, without differences between groups.
Details
- Language :
- English
- ISSN :
- 0378-7966
- Volume :
- 24
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- European journal of drug metabolism and pharmacokinetics
- Publication Type :
- Academic Journal
- Accession number :
- 10892897
- Full Text :
- https://doi.org/10.1007/BF03190042