[Translation] Pioglitazone Hydrochloride Tablets (15mg) randomized, open, single-dose, two-sequence, two-period, double-crossover bioequivalence pilot test under fasting and fed administration conditions in Chinese healthy subjects
本试验旨在研究单次空腹和餐后口服成都迪康药业股份有限公司研制、生产的盐酸吡格列酮片(15 mg)的药代动力学特征;以Teva Takeda Yakuhin Ltd持证、Takeda Pharmaceutical Company Limited,Hikari Plant生产的盐酸吡格列酮片(艾可拓®,15 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性,并观察两制剂在健康受试者中的安全性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of pioglitazone hydrochloride tablets (15 mg) developed and produced by Chengdu Dikang Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach and after meals; licensed by Teva Takeda Yakuhin Ltd, Takeda Pharmaceutical Company Limited ,Pioglitazone Hydrochloride Tablets (Aiketuo®, 15 mg) produced by Hikari Plant was used as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations were compared, and the human bioequivalence of the two preparations was evaluated, and To observe the safety of the two preparations in healthy subjects.