Hefei Huawei Pharmaceutical Co., Ltd.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of Iguratimod tablets (specification: 25 mg, applicant: Hefei Huawei Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Edexin®, specification: 25 mg, licensee: Hainan Xiansheng Pharmaceutical Co., Ltd.) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects. Secondary study objectives To study the safety of the test formulation of Iguratimod tablets (specification: 25 mg) and the reference formulation (trade name: Edexin®, specification: 25 mg) in healthy Chinese adult subjects.

This study aimed to study the pharmacokinetic characteristics of bilastine oral solution (4 mL: 10 mg) developed and produced by Hefei Huawei Pharmaceutical Co., Ltd. after a single fasting oral administration in healthy subjects; using bilastine tablets (Bilaxten®, 20 mg) produced by Faes Farma, S.A. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, to evaluate the human bioequivalence of the two preparations, and to observe the safety of the two preparations in healthy subjects.

Primary objective: To evaluate the effectiveness of pilocarpine hydrochloride eye drops in the treatment of presbyopic patients; Secondary objective: To evaluate the pharmacokinetic characteristics and safety of pilocarpine hydrochloride eye drops in presbyopic patients.