[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover, fasting and postprandial clinical study to evaluate the bioequivalence of pioglitazone-metformin tablets and Miguro® combined tablets LD in Chinese healthy adult subjects
主要目的:
以宁波美舒医药科技有限公司委托宁波美诺华天康药业有限公司生产的吡格列酮二甲双胍片为受试制剂(规格:15mg/500mg),按生物等效性试验的有关规定,与武田テバ薬品株式会社持有的吡格列酮二甲双胍片(商品名:メタクト®配合錠LD,规格:15mg/500mg)为参比制剂,进行生物等效性试验,比较两种制剂在空腹和餐后条件下单次给药的生物等效性。
次要目的:
评估单剂口服受试制剂(吡格列酮二甲双胍片,T)和参比制剂(メタクト®配合錠LD,R)在中国健康成年受试者中的安全性。
[Translation] main purpose:
The pioglitazone and metformin tablets produced by Ningbo Meihua Tiankang Pharmaceutical Co., Ltd. entrusted by Ningbo Meisu Pharmaceutical Technology Co., Ltd. were used as the test preparation (specification: 15mg/500mg). According to the relevant regulations of bioequivalence testing, it was compared with Takeda Tuopin Co., Ltd. The company's pioglitazone and metformin tablets (trade name: Mikuto® Formulated Tablets LD, specifications: 15mg/500mg) are used as reference preparations. Bioequivalence tests are conducted to compare the two preparations in single doses under fasting and postprandial conditions. of bioequivalence.
Secondary purpose:
To evaluate the safety of a single oral dose of the test preparation (Pioglitazone and Metformin Tablets, T) and the reference preparation (Pioglitazone® Tablets LD, R) in healthy Chinese adult subjects.