Jiangmen Hengjian Pharmaceutical Co. Ltd.

Desonide lotion (0.05% (0.5 mg/g)) supplied by Guangdong Hengjian Pharmaceutical Co., Ltd. was used as the test formulation, and desonide lotion (0.05% (0.5 mg/g); trade name: Desowen®) certified by Galderma Australia Pty Ltd was used as the reference formulation. 1) To study the in vivo exposure of the test and reference formulations after topical administration, and to evaluate the safety of the test formulation. 2) To explore the dose-response relationship of different doses in healthy participants in Chinese trials, to obtain an appropriate dosage, and to provide a reference for preliminary dose-duration-effect studies and pivotal human bioequivalence studies. 3) To obtain the dose-duration (ED50) for reference in pivotal human bioequivalence studies. 4) To conduct human bioequivalence studies, and to evaluate the bioequivalence of the two formulations by comparing their pharmacodynamic parameters.

Primary Study Objective: In accordance with relevant bioequivalence testing regulations, esomeprazole magnesium enteric-coated capsules (trade name: NEXIUM®, strength: 40mg), manufactured by Astrazeneca Pharmaceuticals Lp, was selected as the reference formulation. A postprandial administration bioequivalence study was conducted on the test formulation, esomeprazole magnesium enteric-coated capsules (strength: 40mg), manufactured and supplied by Guangdong Hengjian Pharmaceutical Co., Ltd. The study aimed to compare whether the differences in the absorption rate and extent of the drug in the test formulation with those in the reference formulation were within acceptable limits, and to evaluate the bioequivalence of the two formulations under postprandial administration conditions. Secondary Study Objective: To observe the safety of oral administration of the test formulation, esomeprazole magnesium enteric-coated capsules (strength: 40mg), and the reference formulation, esomeprazole magnesium enteric-coated capsules (trade name: NEXIUM®, strength: 40mg), in healthy participants.

Primary Objective: This study used budesonide enteric-coated capsules (4 mg) manufactured and owned by Guangdong Hengjian Pharmaceutical Co., Ltd. as the test formulation, and budesonide enteric-coated capsules (4 mg, trade name: NEFECON®) owned by Everest Medicines (Singapore) Pte. Ltd. as the reference formulation, in accordance with relevant regulations for bioequivalence studies, to evaluate the bioequivalence of the test and reference formulations after administration in a fasting state. Secondary Objective: To observe the safety of the test formulation budesonide enteric-coated capsules and the reference formulation budesonide enteric-coated capsules (trade name: NEFECON®) in healthy trial participants.