Jiangsu Wanchuan Medical & Health Industry Group Co., Ltd.

Main purpose: With healthy subjects as the test subjects, a randomized, open, two-period, two-sequence, double-crossover design was used to investigate the in vivo time course of trelagliptin after a single oral administration of Trelagliptin Succinate Tablets (test preparation, specification: 100 mg) produced by Jiangsu Wanhe Pharmaceutical Co., Ltd. (MAH: Nanjing Wanrong Jiancheng Pharmaceutical Technology Co., Ltd.) and Trelagliptin Succinate Tablets (reference preparation, Zafatek ®, specification: 100 mg) produced by Takeda Pharmaceutical Co., Ltd., Japan, to estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in fasting and postprandial states, and provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation (trade name: Zafatek ®) of Trelagliptin Succinate Tablets in healthy subjects.

Main study objectives: This study investigated the pharmacokinetic characteristics of a single oral dose of fludrocortisone acetate tablets (test preparation, specification: 0.1 mg) provided by Jiangsu Fuxinyu Pharmaceutical Technology Co., Ltd. or fludrocortisone acetate tablets (reference preparation, trade name: Florinef®, specification: 0.1 mg) produced by Aspen Japan Co., Ltd. under fasting and postprandial conditions, and evaluated the bioequivalence between the two preparations. Secondary study objectives: Observe the safety of a single oral dose of 0.1 mg of the test preparation fludrocortisone acetate tablets (specification: 0.1 mg) or the reference preparation fludrocortisone acetate tablets (trade name: Florinef®, specification: 0.1 mg) in healthy subjects.

The primary study objective is to evaluate the absorption rate and extent of fludrocortisone acetate tablets and FLORINEF® in healthy male and female subjects after meals, and to evaluate whether the two preparations are bioequivalent. The secondary study objective is to evaluate the safety of the test preparation fludrocortisone acetate tablets and the reference preparation FLORINEF® in healthy Chinese subjects.