Sichuan Viao Pharmaceutical Co., Ltd.

Miglitol Tablets (trade name: Ao Tian Ping®, specification: 50 mg) produced by Sichuan Wei Ao Pharmaceutical Co., Ltd. were used as the test preparation, and Miglitol Tablets (trade name: GLYSET®, specification: 50 mg) produced by Bayer AG of Germany were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the relative bioavailability and pharmacodynamic data of the two preparations in healthy humans were compared to investigate the human bioequivalence of the two preparations in terms of PK and PD.

To investigate the bioequivalence of a single oral dose of domperidone tablets to a reference formulation (Motilium®) in healthy Chinese volunteers on an empty stomach or after a high-fat meal.

The pharmacokinetic characteristics of the test formulation of domperidone tablets (10 mg/tablet; Sichuan Via Pharmaceutical Co., Ltd.) and the reference formulation of domperidone tablets (Motilium® 10 mg/tablet; Janssen-Cilag) were studied in healthy Chinese subjects after a single oral administration on an empty stomach, and the possibility of bioequivalence of the two formulations in subsequent formal trials was preliminarily evaluated. The safety of the test formulation and the reference formulation of domperidone tablets after a single oral administration in healthy Chinese subjects was studied.