[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of metformin hydrochloride extended-release tablets (strength: 500 mg) and the reference formulation of Glucophage® SR (strength: 500 mg) in healthy adult participants in the fasting and fed state
主要研究目的:评估空腹和餐后状态下单次口服受试制剂盐酸二甲双胍缓释片(规格:500 mg,南京亿华药业有限公司生产)与参比制剂盐酸二甲双胍缓释片(Glucophage® SR,规格:500 mg,Merck Serono Ltd生产)在健康参与者体内的药代动力学参数,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸二甲双胍缓释片(规格:500 mg)和参比制剂盐酸二甲双胍缓释片(Glucophage® SR,规格:500 mg)在健康参与者中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetic parameters of the test preparation metformin hydrochloride extended-release tablets (specification: 500 mg, produced by Nanjing Yihua Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride extended-release tablets (Glucophage® SR, specification: 500 mg, produced by Merck Serono Ltd) in healthy participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study is to evaluate the safety of the test preparation metformin hydrochloride extended-release tablets (specification: 500 mg) and the reference preparation metformin hydrochloride extended-release tablets (Glucophage® SR, specification: 500 mg) in healthy participants.