Hefei Huawei Pharmaceutical Co., Ltd.

A single-center, randomized, open-label, single-dose, two-period, two-sequence crossover bioequivalence study of acetylcysteine oral solution in Chinese healthy subjects under fasting and fed conditions

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.