1. Pharmacokinetic comparison between Conpremin (Premarin) and a generic preparation of conjugated estrogens.
- Author
-
Arteaga E and Villaseca P
- Subjects
- Adult, Biological Availability, Chile, Cross-Over Studies, Equilin blood, Equilin pharmacokinetics, Estradiol blood, Estradiol pharmacokinetics, Estrone blood, Estrone pharmacokinetics, Female, Humans, Middle Aged, Postmenopause, Therapeutic Equivalency, United States, Drugs, Generic pharmacokinetics, Equilin analogs & derivatives, Estrogens, Conjugated (USP) pharmacokinetics
- Abstract
Objectives: To determine the relative bioavailability of the estrogenic components of a generic brand of conjugated estrogens marketed in Chile in comparison to that of Conpremin (Premarin in the United States)., Methods: A randomized cross-over study was conducted on 16 healthy postmenopausal women receiving single oral doses of either two Conpremin 0.625-mg tablets or two 0.625-mg tablets of the generic brand, with a 14-day wash-out interval between doses. A gas chromatography tandem mass spectrometry assay was used to determine estrogen components., Results: The peak plasma concentrations of unconjugated and total estrone and equilin, unconjugated 17 beta-dihydroequilin and 17 beta-estradiol were higher and occurred earlier with the generic conjugated estrogens than with Conpremin. The 90% confidence limits for both variables lay outside the accepted bioequivalence limits of 80-125%. Additionally, no measurable plasma concentration of unconjugated delta 8,9-dehydroestrone or 17 beta-delta 8,9-dehydroestradiol was seen after administration of the generic conjugated estrogens., Conclusions: These pharmacokinetic results indicate that the generic tablets do not have the modified-release characteristics of Conpremin tablets. In addition, the absence of delta 8,9-dehydroestrone and 17 beta-delta 8,9-dehydroestradiol in the plasma indicates that the generic form is not compositionally equivalent to Conpremin.
- Published
- 1998
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