[Translation] A single-center, open, randomized, single-dose, two-period, two-sequence, two-crossover bioequivalence study of oral calcitriol soft capsules in healthy subjects with fasting or after meals
主要研究目的:以江苏中治制药有限公司提供的骨化三醇软胶囊剂(0.25μg/粒)为受试制剂,以Catalent Germany Eberbach GmbH的骨化三醇胶丸(0.25μg/粒,商品名:罗盖全®)为参比制剂,评估受试制剂和参比制剂在空腹及餐后条件下给药后的生物等效性。
次要研究目的:观察空腹及餐后条件下受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study is to use the calcitriol soft capsules (0.25μg/capsule) provided by Jiangsu Zhongzhi Pharmaceutical Co., Ltd. as the test preparation and the calcitriol capsules (0.25μg/capsule, trade name: Luogaiquan®) provided by Catalent Germany Eberbach GmbH as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting and postprandial conditions.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy subjects under fasting and postprandial conditions.