Guangzhou Aige Biotechnology Co., Ltd

Main purpose: Calcitriol soft capsules (specification: 0.25μg) of Guangzhou Aige Biotechnology Co., Ltd. were used as the test preparation, and Calcitriol soft capsules (specification: 0.25μg, trade name: Rocaltrol®) of Roche Pharma (Schweiz) were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy subjects was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary objective: To compare the differences in the extent and rate of absorption of topirastat tablets (60 mg/tablet) produced by Jiangsu Zhiyuan Pharmaceutical Co., Ltd. and topirastat tablets (60 mg/tablet, trade name: URIADEC®) produced by Fujiyakuhin Co., Ltd. (Fuji Pharmaceutical Co., Ltd., Japan) in healthy people under fasting and postprandial administration conditions. Secondary objective: To evaluate the safety and tolerability of topirastat tablets (60 mg/tablet) produced by Jiangsu Zhiyuan Pharmaceutical Co., Ltd. under fasting and postprandial conditions.

The pharmacokinetic characteristics of the test preparation Apremilast Tablets (Specification: 30 mg/tablet, produced by Zhaoke Pharmaceutical (Guangzhou) Co., Ltd.) and the reference preparation Apremilast Tablets (trade name: Otezla, specification: 30 mg/tablet, produced by Celgene) were observed in the subjects after a single oral administration of 30 mg, and the bioequivalence of the two preparations on an empty stomach and after a meal was evaluated. At the same time, the safety of the test preparation and the reference preparation after oral administration was observed.