[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test preparation menatetrenone soft capsule (specification: 15 mg) and the reference preparation Gulikang® (specification: 15 mg) in healthy Chinese 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口服受试制剂四烯甲萘醌软胶囊(规格:15mg,持证商:北京柏雅联合药物研究所有限公司)与参比制剂四烯甲萘醌软胶囊(固力康®,规格:15mg,持证商:EisaiCo.,Ltd.)在健康受试者体内的药代动力学特征,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:评估受试制剂四烯甲萘醌软胶囊(规格:15mg)和参比制剂四烯甲萘醌软胶囊(固力康®,规格:15mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation tetrafenone soft capsule (specification: 15mg, license holder: Beijing Boya United Pharmaceutical Research Institute Co., Ltd.) and the reference preparation tetrafenone soft capsule (Gulikang®, specification: 15mg, license holder: Eisai Co., Ltd.) in healthy subjects 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 tetrafenone soft capsule (specification: 15mg) and the reference preparation tetrafenone soft capsule (Gulikang®, specification: 15mg) in healthy subjects.