Sichuan Otsuka Pharmaceutical Co. Ltd.

Procaterol Hydrochloride Granules (Specification: 25μg, 0.25 g/bag) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant provisions of bioequivalence studies, Procaterol Hydrochloride Granules (Specification: 0.01%, 100 g/bottle, trade name: Meptin®) produced by Otsuka Pharmaceutical Co., Ltd. was used as the reference preparation. The pharmacokinetic characteristics of the two preparations in healthy subjects were investigated, and the bioequivalence of the test preparation and the reference preparation under fasting and postprandial conditions was evaluated. Secondary study objective: To evaluate the safety and tolerability of the test preparation Procaterol Hydrochloride Granules (Specification: 25μg, 0.25 g/bag) and the reference preparation Procaterol Hydrochloride Granules (Specification: 0.01%, 100 g/bottle, trade name: Meptin®) in healthy subjects.

Main purpose of the study: Procaterol hydrochloride granules (specification: 0.01%, 50 g/bottle) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence study, Procaterol hydrochloride granules (specification: 0.01%, 100 g/bottle, trade name: Meptin®) produced by Otsuka Pharmaceutical Co., Ltd. were used as the reference preparation to investigate the relative bioavailability of the two preparations under fasting and postprandial conditions, and to conduct a preliminary evaluation of the bioequivalence of the test preparation and the reference preparation, so as to provide reference data for formal clinical drug trials. Secondary purpose of the study: To evaluate the safety and tolerability of Procaterol hydrochloride granules compared with the reference preparation in healthy subjects.

Ambroxol hydrochloride capsules (specification: 30 mg/capsule, trade name: Tanjing®) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence study, ambroxol hydrochloride tablets (specification: 30 mg/tablet, trade name: Mucosolvan®) produced by Boehringer Ingelheim France were used as the reference preparation. The bioavailability of the two preparations was investigated, and the bioequivalence of the test preparation and the reference preparation was evaluated to provide reference data for clinical use.