[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study was conducted in Chinese healthy participants to compare pioglitazone metformin tablets (15 mg/500 mg) developed by Beijing Taiyang Pharmaceutical Co., Ltd. with pioglitazone metformin tablets (Metactone LD®, 15 mg/500 mg) licensed by Takeda Pharmaceutical Co., Ltd., under fasting 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,武田テバ薬品株式会社持证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] Using pioglitazone-metformin tablets (15 mg/500 mg) developed by Beijing Taiyang Pharmaceutical Co., Ltd. as the test formulation and pioglitazone-metformin tablets (trade name: Metakto LD®, 15 mg/500 mg) licensed by Takeda Pharmaceutical Co., Ltd. as the reference formulation, the pharmacokinetic parameters and relative bioavailability of the two formulations under single-dose administration in an empty stomach were investigated to evaluate their bioequivalence. The safety and tolerability of both formulations in healthy individuals were also evaluated.