[Translation] A bioequivalence study of tetraene-menaquinone soft capsules in healthy participants under fasting/postprandial conditions using a single-dose, randomized, open-label, four-period, two-sequence, fully replicated crossover design.
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,浙江莎普爱思药业股份有限公司生产)与参比制剂四烯甲萘醌软胶囊(商品名:固力康®,规格:15mg,Shibakawa Plant of Fuji Capsule Co.,Ltd.生产)在健康成年试验参与者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
评价健康试验参与者空腹和餐后单次口服受试制剂(T)四烯甲萘醌软胶囊和参比制剂(R)四烯甲萘醌软胶囊(固力康®)后的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation, tetraenemannaquinone soft capsules (15 mg, manufactured by Zhejiang Shapuaisi Pharmaceutical Co., Ltd.), and the reference formulation, tetraenemannaquinone soft capsules (trade name: Gulikang®, 15 mg, manufactured by Shibakawa Plant of Fuji Capsule Co., Ltd.), in healthy adult participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial administration.
Secondary Objective: To evaluate the safety of a single oral dose of the test formulation (T) tetraenemannaquinone soft capsules and the reference formulation (R) tetraenemannaquinone soft capsules (Gulikang®) in healthy participants under fasting and postprandial conditions.