[Translation] A single-center, open-label, randomized, single-dose, two-sequence crossover bioequivalence study to evaluate the test product, finerenone tablets, and the reference product, finerenone tablets, in healthy adult participants in the fasting and fed state
主要研究目的:研究空腹和餐后状态下单次口服受试制剂非奈利酮片(规格:10 mg,重庆康刻尔制药股份有限公司生产)与参比制剂非奈利酮片(Kerendia®,规格:10 mg,Bayer AG生产)在健康参与者体内的药代动力学,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:评估受试制剂非奈利酮片(规格:10 mg)和参比制剂非奈利酮片(Kerendia®,规格:10 mg)在健康参与者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation finerenone tablets (specification: 10 mg, produced by Chongqing Kangkeer Pharmaceutical Co., Ltd.) and the reference preparation finerenone tablets (Kerendia®, specification: 10 mg, produced by Bayer AG) 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: to evaluate the safety of the test preparation finerenone tablets (specification: 10 mg) and the reference preparation finerenone tablets (Kerendia®, specification: 10 mg) in healthy participants.