[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of calcitriol capsules (0.25 μg) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择Catalent Germany Eberbach GmbH为生产厂家的骨化三醇胶丸(商品名:Rocaltrol®,规格:0.25μg/粒)为参比制剂,对浙江浙北药业有限公司生产的受试制剂骨化三醇胶丸(规格:0.25μg/粒)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的:观察健康受试者口服受试制剂骨化三醇胶丸(规格:0.25μg/粒)和参比制剂骨化三醇胶丸(商品名:Rocaltrol®,规格:0.25μg/粒)的安全性。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, calcitriol capsules (trade name: Rocaltrol®, specification: 0.25μg/pill) produced by Catalent Germany Eberbach GmbH were selected as the reference preparation. The test preparation calcitriol capsules (specification: 0.25 μg/pill) produced by Zhebei Pharmaceutical Co., Ltd. were subjected to fasting and postprandial administration human bioequivalence tests to compare the absorption speed and absorption of the drug in the test preparation. Whether the degree of difference from the reference preparation is within the acceptable range, evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the oral administration of the test preparation calcitriol capsules (specification: 0.25μg/pill) and the reference preparation calcitriol capsules (trade name: Rocaltrol®, specification: 0.25μg/) to healthy subjects. granules) safety.