[Translation] Single-center, randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial of calcitriol soft capsules in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂骨化三醇软胶囊(持证商:浙江华润三九众益制药有限公司)与参比制剂骨化三醇胶丸(持证商:Roche Pharma(Schweiz)AG,商品名:罗盖全®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂骨化三醇软胶囊和参比制剂骨化三醇胶丸在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation calcitriol soft capsule (license holder: Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd.) and The pharmacokinetic behavior of the reference preparation calcitriol capsules (licensee: Roche Pharma (Schweiz) AG, trade name: Roche®) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations. effectiveness.
Secondary purpose: To observe the safety of the test preparation calcitriol soft capsules and the reference preparation calcitriol capsules in healthy subjects.