醋酸甲羟孕酮：两种口服制剂的稳态药代动力学生物等效性
Medroxyprogesterone acetate: steady-state pharmacokinetics bioequivalence of two oral formulations.
作者信息
Pollow K, Kreienberg R, Di Pietro N
机构信息
Abteilung für Experimentelle Endokrinologie, Universitätsfrauenklinik Johannes-Gutenberg-Universität Mainz, Federal Republic of Germany.
出版信息
J Cancer Res Clin Oncol. 1989;115(4):397-9. doi: 10.1007/BF00400970.
Abstract
Two micronized oral formulations of medroxyprogesterone acetate (MPA) (Farlutal and Clinovir) were compared in order to evaluate their relative bioavailability. Sixteen female patients with metastatic breast cancer were entered in a randomized cross-over study on 500-mg MPA tablets repeatedly administered (twice daily for 20 days). At the steady state, similar mean +/- SD serum levels of MPA were obtained (131 +/- 44 ng/ml for Farlutal and 136 +/- 45 ng/ml for Clinovir) and the two formulations proved to be bioequivalent (confidence interval at a significance level of 0.95 = 93%-107%).
摘要
比较了两种醋酸甲羟孕酮（MPA）的微粉化口服制剂（法乐通和环丙孕酮），以评估它们的相对生物利用度。16名转移性乳腺癌女性患者进入一项关于500毫克MPA片剂重复给药（每日两次，共20天）的随机交叉研究。在稳态时，获得了相似的MPA平均±标准差血清水平（法乐通为131±44纳克/毫升，环丙孕酮为136±45纳克/毫升），并且两种制剂被证明具有生物等效性（显著性水平为0.95时的置信区间=93%-107%）。
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