[Translation] A randomized, open-label, fasting single-dose, two-preparation, two-sequence, two-cycle crossover bioequivalence trial of bromhexine hydrochloride granules in Chinese adult healthy subjects
主要研究目的:
考察空腹单次口服受试制剂盐酸溴己新颗粒(规格:4mg,江西亿友药业有限公司生产)与参比制剂盐酸溴己新口服溶液(商品名:Bisolvon®,规格:2mg/mL,Opella Healthcare Italy S.r.l.持证),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:
评价空腹单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main research purposes:
Examine the fasting single oral administration of the test preparation bromhexine hydrochloride granules (specification: 4 mg, produced by Jiangxi Yiyou Pharmaceutical Co., Ltd.) and the reference preparation bromhexine hydrochloride oral solution (trade name: Bisolvon®, specification: 2 mg/mL, Opella Healthcare Italy S.r.l. (certified), analyzed the relative bioavailability of the two preparations in healthy human subjects in China, analyzed the pharmacokinetic parameters of the two preparations, and evaluated the bioequivalence of the two preparations.
Secondary research purpose:
To evaluate the safety of a single oral dose of the test preparation and reference preparation on an empty stomach in Chinese adult healthy subjects.