Mikkelson T J, Kroboth P D, Cameron W J, Dittert L W, Chungi V, Manberg P J
Fertil Steril. 1986 Sep;46(3):392-6. doi: 10.1016/s0015-0282(16)49574-9.
Twenty-four healthy adult female volunteers participated in a randomized, three-phase double-blind crossover trial comparing the single-dose (50 mg) pharmacokinetics of three formulations of clomiphene citrate (CC). Plasma levels of both the Z(cis) and E(trans) isomers of CC, as well as principal metabolites, were determined at periodic intervals; and no differences between formulations were observed. The active Z isomer attained peak blood levels later than the inactive E isomer and was eliminated much more slowly, significant plasma concentrations still being detected up to 1 month after treatment. The results of this study demonstrate that three commercially available formulations of CC are bioequivalent.
24名健康成年女性志愿者参与了一项随机、三阶段双盲交叉试验，比较了三种枸橼酸氯米芬（CC）制剂的单剂量（50毫克）药代动力学。在不同时间间隔测定了CC的Z（顺式）和E（反式）异构体以及主要代谢物的血浆水平；未观察到制剂之间的差异。活性Z异构体达到血药峰值的时间比无活性的E异构体晚，且消除速度慢得多，在治疗后1个月仍可检测到显著的血浆浓度。本研究结果表明，三种市售CC制剂具有生物等效性。
