[Translation] A randomized, open-label, fasting and postprandial single-dose, two-drug, two-sequence, two-period crossover bioequivalence study of idecalcitol soft capsules in Chinese adult healthy subjects
主要研究目的:考察空腹/餐后条件下单次口服0.5μg受试制剂艾地骨化醇软胶囊(规格:0.5μg/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:0.5μg/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0.5μg在中国成年健康受试者中的安全性。
[Translation] The main purpose of the study: To investigate the single oral administration of 0.5 μg of the test preparation Idecalcitol Soft Capsules (specification: 0.5 μg/capsule, produced by Zhengda Pharmaceutical (Qingdao) Co., Ltd.) and the reference preparation Idecalcitol under fasting/after meals conditions. Pharmacokinetic characteristics of Huaol Soft Capsules (trade name: EDIROL®, specification: 0.5 μg/capsule, produced by Chugai Pharmaceutical Co., Ltd.) in Chinese adult healthy subjects, evaluating the fasting and postprandial states of oral administration of two preparations respectively bioequivalence. Secondary research purpose: To evaluate the safety of a single oral administration of 0.5 μg of the test preparation and the reference preparation under fasting/fed conditions in Chinese adult healthy subjects.