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BCM347 is an oral soluble film (OSF) formulation of ambroxol hydrochloride, a mucolytic agent used to treat respiratory diseases characterized by viscous sputum. Developed by Shanghai Bozhi Yanshen Pharmaceutical Technology, BCM347 is designed to provide a more convenient administration route compared to traditional oral solutions or tablets, particularly for patients with swallowing difficulties. Ambroxol works by increasing the secretion of surfactant and reducing mucus viscosity, thereby facilitating expectoration. A Phase 1 clinical trial (CTR20234119) evaluated its bioequivalence and pharmacokinetics compared to the reference drug Mucosolvan (ambroxol hydrochloride oral solution) in healthy adult volunteers under fasting conditions, also assessing different administration methods, palatability, and oral tolerability.
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