Shanghai Bocimed Pharmaceutical Co., Ltd.

Primary objective: To observe the in vivo pharmacokinetic process of brepirazole after a single oral administration of brepirazole orodispersible film in healthy Chinese adult subjects under fasting and fed conditions, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence of brepirazole tablets (trade name: REXULTI®) certified by Otsuka Pharmaceutical Co Ltd as the reference preparation. Secondary objectives: 1. To observe the safety of brepirazole orodispersible film (test preparation) and brepirazole tablets (trade name: REXULTI®, reference preparation) in healthy humans; 2. To compare the effects of different administration methods (water and no water) on the relative bioavailability of the test preparation under fasting conditions; 3. To evaluate the mouthfeel (palatability), grittiness, dissolution time, mucosal adhesion and irritation of brepirazole orodispersible film (test preparation, no water).

Main purpose: To observe the in vivo kinetics of ambroxol hydrochloride after a single oral administration of BCM347 orodispersible film in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence of ambroxol hydrochloride oral solution (trade name: Mucosolvan) licensed by Opella Healthcare Austria GmbH and marketed in the EU as the reference preparation. Secondary objectives: 1. To observe the safety of BCM347 orodispersible film (test preparation) and ambroxol hydrochloride oral solution (trade name: Mucosolvan®, reference preparation) in healthy humans; 2. To compare the effects of different administration methods (water and no water conditions) of the test preparation on relative bioavailability under fasting conditions; 3. To evaluate the mouth feel (palatability) of BCM347 orodispersible film (test preparation, no water conditions) and ambroxol hydrochloride oral solution (reference preparation) in subjects; 4. To investigate and record the dissolution time, mucosal adhesion and irritation of BCM347 orodispersible film (test preparation, no water conditions) in the oral cavity.

Preliminary test: Preliminary exploratory evaluation of the PK parameters of BCM235 sustained-release dry suspension and ibuprofen suspension to provide a basis for the next clinical study. Single/multiple-dose PK study: Main purpose: Using ibuprofen suspension produced by Shanghai Johnson Pharmaceutical Co., Ltd. as a control, study the pharmacokinetic characteristics and bioavailability of BCM235 sustained-release dry suspension, and investigate the bioequivalence between BCM235 sustained-release dry suspension and ibuprofen suspension. Secondary purpose: Observe the safety of BCM235 sustained-release dry suspension and ibuprofen suspension in healthy humans.