[Translation] Evaluation of the test formulation Metformin Empagliflozin Tablets 500 mg/5 mg and the reference formulation Synjardy® 500
mg/5 mg (metformin empagliflozin tablets) in healthy adult participants in the postprandial state in a single-center,
Open-label, randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence trial
主要试验目的:研究空腹和餐后状态下单次口服受试制剂二甲双胍恩格列净片500 mg/5 mg(宁波美诺华天康药业有限公司生产)与参比制剂Synjardy® 500 mg/5 mg(二甲双胍恩格列净片)(Boehringer Ingelheim 生产)在健康成年参与者体内的药代动力学特征,评价餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂二甲双胍恩格列净片500 mg/5 mg与参比制剂Synjardy® 500 mg/5 mg(二甲双胍恩格列净片)在健康成年参与者中的安全性。
[Translation] Main purpose of the trial: To study the single oral administration of the test preparation Metformin Empagliflozin Tablets 500 mg/5 mg (produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd.) and the reference preparation Synjardy® 500 mg/5 under fasting and postprandial conditions. Pharmacokinetic characteristics of mg (metformin empagliflozin tablets) (manufactured by Boehringer Ingelheim) in healthy adult participants to evaluate the bioequivalence of the two oral formulations in the postprandial state.
Secondary trial purpose: To study the safety of the test preparation Metformin Empagliflozin Tablets 500 mg/5 mg and the reference preparation Synjardy® 500 mg/5 mg (Metformin Empagliflozin Tablets) in healthy adult participants.