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

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.

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.