[Translation] A randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of idecalcitol soft capsules in healthy Chinese adult subjects
主要研究目的:
考察空腹/餐后条件下单次口服0.75μg受试制剂艾地骨化醇软胶囊(规格:0.75μg/粒,正大制药(青岛)有限公司生产)与参比制剂艾地骨化醇软胶囊(商品名:EDIROL®,规格:0.75μg/粒,中外製薬株式会社生产)在中国成年健康受试者体内的药代动力学特征,评价空腹与餐后状态分别口服两种制剂的生物等效性。
次要研究目的:
评价受试制剂和参比制剂空腹/餐后条件下单次口服0.75μg在中国成年健康受试者中的安全性。
[Translation] Main research purposes:
Examine the single oral administration of 0.75 μg of the test preparation idecalcitol soft capsule (specification: 0.75 μg/capsule, produced by Chia Tai Pharmaceutical (Qingdao) Co., Ltd.) and the reference preparation idecalcitol soft capsule under fasting/postprandial conditions. (Trade name: EDIROL®, specification: 0.75μg/tablet, manufactured by Chugai Seiko Co., Ltd.) Pharmacokinetic characteristics in Chinese adult healthy subjects, and evaluation of the bioequivalence of the two preparations taken orally in the fasting and postprandial states effectiveness.
Secondary research purpose:
To evaluate the safety of a single oral dose of 0.75 μg of the test preparation and reference preparation in Chinese adult healthy subjects under fasting/postprandial conditions.