Bioequivalence of a newly developed 17 beta-estradiol tablet versus an identical reference formulation
Two open-label, randomized studies determined the bioequivalence of a test preparation (Prefest) of micronized 17 beta-estradiol (E2, CAS 50-28-2) tablets as compared with a reference preparation of micronized E2 tablets in healthy postmenopausal women. In Study 1, 36 fasting subjects received 4 test preparation 0.5-mg E2 tablets in one period and 4 reference preparation 0.5-mg E2 tablets in the other period. In Study 2, 36 fasting subjects received 1 test preparation 2-mg E2 tablet in one period and 1 reference preparation 2-mg E2 tablet in the other period. Blood samples were collected before and after dosing to determine serum concentrations of E2, estrone, and estrone sulfate. The 90% confidence intervals for the ratios of mean Cmax and AUC values (test preparation/reference preparation) for all three analytes were within the prescribed 80%-125% range of bioequivalence. In conclusion, the test preparation 0.5-mg and 2-mg micronized E2 tablets are bioequivalent to the respective strength reference preparation micronized E2 tablets.
Gisclon
LG
R. W. Johnson Pharmaceutical Research Institute, Spring House, PA, USA.
Bowen
AJ
O'Reilly
TE
Lakewold
D
Curtin
CR
Larson
KL
Palmer
SA
Natarajan
J
Wong
FA