Zhejiang Hisoar Pharmaceutical Co., Ltd.

Main study objectives: To study the pharmacokinetics of the test preparation repaglinide tablets (specification: 1.0 mg, produced by Zhejiang Haixiang Pharmaceutical Co., Ltd.) and the reference preparation repaglinide tablets (Novolong®, specification: 1.0 mg, produced by Boehringer Ingelheim Pharma GmbH & Co.KG, Germany) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary study objectives: To evaluate the safety of the test preparation and reference preparation of repaglinide tablets in healthy subjects after a single oral administration in the fasting and fed state.

The purpose of this study was to study the pharmacodynamic characteristics of a single oral administration of voglibose tablets (0.2 mg) produced by Zhejiang Hisun Pharmaceutical Co., Ltd. on an empty stomach, and to use voglibose tablets (trade name: Beixin®, specification: 0.2 mg) produced by Tianjin Takeda Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacodynamic parameters of the two preparations, and to evaluate the bioequivalence of the two preparations under fasting conditions.

A dose-finding study was conducted to determine the optimal dosage of voglibose tablets for conducting a bioequivalence study in healthy Chinese volunteers.