Chengdu Pharmaceutical Co. Ltd.

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and absorption rate between cloperidone hydrochloride tablets (specification: 10 mg) produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group and cloperidone hydrochloride tablets (trade name: HUSTAZOL®, specification: 10 mg) produced by Nipro ES Pharma Co., Ltd. in healthy Chinese people under the condition of postprandial administration, and to evaluate the safety of cloperidone hydrochloride tablets produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group.

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and rate between cloperidine hydrochloride tablets (specification: 10 mg) produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group and cloperidine hydrochloride tablets (trade name: HUSTAZOL®, specification: 10 mg) produced by Nipro ES Pharma Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of cloperidine hydrochloride tablets produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group.

The time course of blood drug concentration after a single oral dose of the test preparation bromhexine hydrochloride tablets (8 mg, produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group) was observed in healthy subjects in the fasting and postprandial states, and the corresponding pharmacokinetic parameters were estimated. A formal bioequivalence study was conducted using bromhexine hydrochloride tablets (8 mg, licensed by Sanofi-Aventis Deutschland GmbH, produced by Delpharm Reims, France, trade name: Bisolvon®) as the reference preparation.