Jiangsu Foursea Pharmaceutical Technology Co., Ltd.

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.

Primary study objective: To evaluate the absorption rate and extent of fludrocortisone acetate tablets and FLORINEF® in healthy male and female subjects under fasting conditions, and to evaluate whether the two preparations are bioequivalent. Secondary study objective: To evaluate the safety of the test preparation fludrocortisone acetate tablets and the reference preparation FLORINEF® in healthy Chinese subjects.