[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test product Probucol Tablets (strength: 0.25 g) and the reference product Lorelco® (strength: 250 mg) in healthy adult participants in the fed state
主要研究目的:评估餐后状态下单次口服受试制剂普罗布考片(规格:0.25 g)与参比制剂普罗布考片(Lorelco®,规格:250 mg,大塚製薬株式会社生产)在健康参与者体内的药代动力学参数,评价餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂普罗布考片(规格:0.25 g)和参比制剂普罗布考片(Lorelco®,规格:250 mg)在健康参与者中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetic parameters of the test preparation probucol tablets (specification: 0.25 g) and the reference preparation probucol tablets (Lorelco®, specification: 250 mg, produced by Otsuka Pharmaceutical Co., Ltd.) in healthy participants after a single oral administration in the fed state, and to evaluate the bioequivalence of the two oral preparations in the fed state.
Secondary study objective: To evaluate the safety of the test formulation, probucol tablets (strength: 0.25 g) and the reference formulation, probucol tablets (Lorelco®, strength: 250 mg) in healthy participants.