Saperstein S, Edgren R A, Ellis D J, Lee G J, Kushinsky S, Olmsted A, Mroszczak E
Contraception. 1986 Jun;33(6):547-57. doi: 10.1016/0010-7824(86)90043-0.
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 (EE2). 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 EE2, 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 (AUC24) and total area under the curve (AUC+o+) for both NET and EE2 and with respect to concentration maximum (Cmax) for EE2. The data support the hypothesis for bioequivalence of the two formulations with respect to total absorption.
对两种不同重量的口服避孕药片（100毫克的A片和50毫克的B片）进行了相互比较，并与相同成分的溶液（C）进行了比较。该口服避孕药的成分包括1毫克炔诺酮（NET）和0.035毫克炔雌醇（EE2）。结果显示，两种片剂与吸收更快的溶液存在差异，但彼此之间无显著差异。两种产品各自的NET和EE2制剂均值相似。对计算参数的比值进行区间检验表明，两种制剂在NET和EE2的0至24小时曲线下面积（AUC24）、曲线下总面积（AUC+∞）以及EE2的浓度最大值（Cmax）方面具有等效性。这些数据支持了两种制剂在总吸收方面生物等效性的假设。
