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To evaluate the efficacy and safety of pioglitazone hydrochloride and glimepiride tablets in the treatment of type 2 diabetes mellitus

Male healthy volunteers were selected as subjects. The time course of blood concentrations of pioglitazone and glimepiride after a single oral dose of pioglitazone hydrochloride glimepiride tablets (15mg/1mg) developed by Jiangsu Deyuan Pharmaceutical Co., Ltd. was observed, and the corresponding pharmacokinetic parameters were estimated. Glimepiride tablets (trade name: Amaril) and pioglitazone hydrochloride tablets (trade name: Actos) were used as standard reference preparations to evaluate bioavailability and bioequivalence, in order to provide a basis for clinical research of new drugs.

A human bioavailability study of pioglitazone-glimepiride tablets was conducted on healthy subjects to investigate the relative bioavailability of pioglitazone-glimepiride tablets and pioglitazone hydrochloride tablets (Actos) produced by Takeda Pharmaceutical Company Limited of Japan and glimepiride tablets (Amaryl) produced by Sanofi-Aventis (Beijing) Pharmaceuticals Co., Ltd., to provide an experimental basis for the formulation of the Phase II clinical trial plan of pioglitazone-glimepiride tablets and to provide a basis for the dosage of clinical medication.