[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover bioequivalence study to evaluate the bioequivalence of the test product, finerenone tablets (strength: 10 mg), and the reference product, Kerendia® (strength: 10 mg), in healthy adult participants under fasting conditions.
主要研究目的:评估空腹状态下单次口服受试制剂非奈利酮片(规格:10 mg,甘李药业山东有限公司生产)与参比制剂非奈利酮片(Kerendia®,规格:10 mg,Bayer AG生产)在健康成年参与者中的生物等效性。
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,Bayer AG生产)在健康成年参与者中的安全性。
[Translation] Primary study objective: To evaluate the bioequivalence of a single oral dose of the test product finerenone tablets (10 mg, produced by Ganli Pharmaceutical Shandong Co., Ltd.) and the reference product finerenone tablets (Kerendia®, 10 mg, produced by Bayer AG) in healthy adult participants under fasting conditions.
Secondary study objective: To evaluate the safety of the test product finerenone tablets (10 mg) and the reference product finerenone tablets (Kerendia®, 10 mg, produced by Bayer AG) in healthy adult participants.