Shenzhen Beimei Pharmaceutical Co., Ltd.

Primary objective: This study aims to study the pharmacokinetic characteristics of a single fasting oral administration of bilastine oral solution (120 mL: 0.3 g) developed by Shenzhen Beimei Pharmaceutical Co., Ltd. in healthy subjects; using the bilastine tablets (Bilaxten®, 20 mg) certified by Faes Farma, S.A. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

The main purpose of the study is to use the sultamicillin dry suspension (trade name: Unacid®; specification: 375 mg/7.5 ml) produced by Haupt Pharma Latina S.r.l. Latina and licensed by PFIZER PHARMA PFE GmbH as the reference preparation and the sultamicillin dry suspension (specification: 5.0 g/bottle) produced by Chengdu Jinhua Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the human body under the fed state through a single-center, randomized, open, single-dose, two-period, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy subjects.

The main purpose of the study is to use the sultamicillin dry suspension (trade name: Unacid®; specification: 375 mg/7.5 ml) produced by Haupt Pharma Latina S.r.l. Latina and licensed by PFIZER PHARMA PFE GmbH as the reference preparation and the sultamicillin dry suspension (specification: 5.0 g/bottle) produced by Chengdu Jinhua Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-period, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy subjects.