China Pharmaceutical University Pharmaceutical Co. Ltd.

Primary Study Objective: To evaluate the pharmacokinetic characteristics and bioequivalence of a single oral dose of celecoxib capsules (test formulation: 0.2g, sponsor: Yaoda Pharmaceutical Co., Ltd.) and reference formulation (trade name: Celebrex®, strength: 0.2g, licensee: Upjohn US 2 LLC) under fasting conditions in healthy adult participants in a Chinese trial. Secondary Study Objective: To investigate the safety of celecoxib capsules (test formulation: 0.2g) and reference formulation (trade name: Celebrex®, strength: 0.2g) in healthy adult participants in a Chinese trial.

Primary objective: To use the crisaborole ointment developed by Yaoda Pharmaceutical Co., Ltd. as the test preparation and the crisaborole ointment (trade name: Sutanming®) licensed by Anacor Pharmaceuticals, Inc. as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations after a single administration under fasting conditions, and to evaluate whether the two preparations are bioequivalent. Secondary objective: To evaluate the safety of the test preparation and reference preparation of crisaborole ointment after a single fasting topical application in healthy Chinese subjects.

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of vonoprazan plasma concentrations in healthy subjects after administration of the test formulation of vonoprazan fumarate tablets produced by Yaoda Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Vonoprazan fumarate tablets (trade name: Vocinti®, specification: 20 mg) produced by Takeda Pharmaceutical Company Limited, Hikari Plant, with a license issued by Takeda Pharmaceutical Company Limited, were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of vonoprazan fumarate tablets in healthy Chinese subjects.