[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study was conducted in healthy Chinese subjects between pioglitazone-metformin tablets (15 mg/500 mg) developed by Beijing Taiyang Pharmaceutical Co., Ltd. and pioglitazone-metformin tablets (Metact LD®, 15 mg/500 mg) licensed by Takeda Teba Pharmaceutical Co., Ltd., under fasting and fed conditions.
以北京太洋药业股份有限公司研制的吡格列酮二甲双胍片(规格:15 mg/500 mg)为受试制剂,持证商为武田テバ薬品株式会社的吡格列酮二甲双胍片(商品名:メタクト 配合錠LD®,规格:15 mg/500 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] The test formulation, pioglitazone-metformin tablets (15 mg/500 mg) developed by Beijing Taiyang Pharmaceutical Co., Ltd., and the reference formulation, pioglitazone-metformin tablets (Metact LD®, 15 mg/500 mg) from Takeda Teba Pharmaceuticals, were used. The pharmacokinetic parameters and relative bioavailability of the two formulations following single administration in the fasting and fed states were investigated to evaluate their bioequivalence. The safety and tolerability of the two formulations in healthy volunteers were also evaluated.