Jiangxi Yiyou Pharmaceutical Co., Ltd.

The primary objective was to observe the time course of plasma drug concentrations of a test formulation, bromhexine hydrochloride tablets (strength: 8 mg, manufacturer: Jiangxi Yiyou Pharmaceutical Co., Ltd.), after a single oral dose in healthy volunteers in the fasting and fed states, and to estimate the corresponding pharmacokinetic parameters. A formal bioequivalence study was conducted in humans using bromhexine hydrochloride tablets (trade name: Bisolvon®, strength: 8 mg, licensee: A. Nattermann & Cie. GmbH) as the reference formulation, to provide a reference for drug registration and clinical application. The secondary objective was to observe the safety of the test and reference formulations after oral administration in the fasting and fed states.

Main study objectives: To investigate the relative bioavailability of the test preparation bromhexine hydrochloride granules (specification: 4mg, produced by Jiangxi Yiyou Pharmaceutical Co., Ltd.) and the reference preparation bromhexine hydrochloride oral solution (trade name: Bisolvon®, specification: 2mg/mL, licensed by Opella Healthcare Italy S.r.l.) in healthy Chinese subjects after a single oral administration on an empty stomach, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation after a single oral administration on an empty stomach in healthy adult Chinese subjects.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of single oral doses of drotaverine hydrochloride tablets (test preparation, specification: 40 mg) produced by Jiangxi Yiyou Pharmaceutical Co., Ltd. and drotaverine hydrochloride tablets (reference preparation, trade name: NO-SPA®, specification: 40 mg) certified by Opella Healthcare France SAS in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of the test preparation (specification: 40 mg) and reference preparation (NO-SPA®, specification: 40 mg) of drotaverine hydrochloride tablets in healthy Chinese adult subjects.