Bioequivalence of norethindrone and ethinyl estradiol for two different weight tablets with the same hormonal content
1986
Abstract Two tablets of differing weights, 100 mg (A) and 50 mg (B), of an oral contraceptive drug (OC) were compared with each other and to a solution (C) of the same components. The composition of the OC consisted of 1 mg of norethindrone (NET) and 0.035 mg of ethinyl estradiol (EE 2 ). Both tablets were shown to differ from the solution, which was more rapidly absorbed, but were not significantly different from each other. Formulation means for NET and EE 2 , for each of the two products, were similar. Application of an interval test for the ratio of computed parameters demonstrated equivalence of the two formulations with respect to 0–24 hr area under the curve (AUC 24 ) and total area under the curve (AUC †o† ) for both NET and EE 2 and with respect to concentration maximum (C max ) for EE 2 . The data support the hypothesis for bioequivalence of the two formulations with respect to total absorption.
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