[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of rebamipide tablets in healthy volunteers after single oral administration on an empty stomach or after a meal
主要研究目的: 研究空腹和餐后状态下单次口服受试制剂瑞巴派特片(规格:0.1g,浙江英格莱制药有限公司生产)与参比制剂瑞巴派特片(Mucosta ®,规格:0.1g,大塚制药株式会社(OTSUKA PHARMACEUTICAL Co.,Ltd.)生产)在健康成年受试者体内的药代动力学,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: 空腹和餐后状态下,研究单次口服受试制剂瑞巴派特片和参比制剂瑞巴派特片(Mucosta ®)在健康成年受试者中的安全性。
[Translation] Primary Study Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation, rebamipide tablets (0.1 g, manufactured by Zhejiang Yinggelai Pharmaceutical Co., Ltd.), compared to a reference formulation, rebamipide tablets (Mucosta®, 0.1 g, manufactured by Otsuka Pharmaceutical Co., Ltd.), in healthy adult volunteers, both in the fasting and fed states, and to evaluate the bioequivalence of the two formulations in both the fasting and fed states.
Secondary Study Objective: To investigate the safety of a single oral dose of the test formulation, rebamipide tablets, compared to a reference formulation, rebamipide tablets (Mucosta®), in healthy adult volunteers, both in the fasting and fed states.