[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover bioequivalence study to evaluate the bioequivalence of the test preparation, Empagliflozin Tablets (10 mg), and the reference preparation, Otangjing® (10 mg), in healthy adult subjects in the fasting and fed state.
主要研究目的:研究空腹和餐后状态下单次给药受试制剂恩格列净片(规格:10 mg,以华益药业科技(安徽)有限公司生产,甘李药业山东有限公司提供)与参比制剂恩格列净片(欧唐静®,规格:10 mg;Boehringer Ingelheim International GmbH & Co. KG生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。 次要研究目的:评估受试制剂恩格列净片(规格:10 mg)与参比制剂恩格列净片(欧唐静®,规格:10 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation empagliflozin tablets (specification: 10 mg, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd. and provided by Ganli Pharmaceutical Shandong Co., Ltd.) and the reference preparation empagliflozin tablets (Otangjing®, specification: 10 mg; produced by Boehringer Ingelheim International GmbH & Co. KG) in healthy subjects after a single dose in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. The secondary purpose of the study is to evaluate the safety of the test preparation empagliflozin tablets (specification: 10 mg) and the reference preparation empagliflozin tablets (Otangjing®, specification: 10 mg) in healthy subjects.