Hubei Shubang Pharmaceutical Co Ltd.

Primary objective: To evaluate the efficacy and safety of fluocinolone hydroquinone retinoic acid cream in the treatment of moderate to severe chloasma. Secondary objective: To evaluate the clinical equivalence of fluocinolone hydroquinone retinoic acid cream and the reference preparation by clinical endpoint method; to clarify the systemic exposure of the test preparation and the reference preparation by monitoring the systemic absorption of the three components of retinoic acid, fluocinolone and hydroquinone in clinical trials.

A single-center, randomized, open-label, two-preparation, two-cycle crossover, and single-dose dosing design was adopted to compare Fudosteine tablets provided by Hubei Shubon Pharmaceutical Co., Ltd. (Specifications: 0.2 g) and Tabe Mitsubishi Co., Ltd.’s certified fudosteine tablets (specification: 0.2 g, trade name: Cleanal®) in the degree and rate of absorption in Chinese healthy people, and to evaluate the differences in the absorption rate of Hubei Shubon Pharmaceuticals Safety of Fodorsteine Tablets offered by Ltd.

Main study purpose Healthy subjects were given a single oral dose of the test preparation Nimesulide dispersible tablets produced by Hubei Shubang Pharmaceutical Co., Ltd. or the reference preparation Nimesulide tablets produced by Helsinn Birex Pharmaceutical Ltd. in the fasting or postprandial state, and the pharmacokinetic parameters of the test preparation and the reference preparation in the healthy subjects were investigated in the fasting and postprandial state, respectively, to evaluate the bioequivalence of the two preparations. Secondary study purpose To investigate the safety of the test preparation and the reference preparation of nimesulide in healthy subjects.