[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully replicated crossover bioequivalence trial evaluating the investigational formulation loratadine tablets (10 mg) and the reference formulation loratadine tablets (Claritin®, 10 mg) in healthy adult trial participants in fasting condition.
主要研究目的:研究空腹状态下单次口服受试制剂氯雷他定片(规格:10 mg,辰欣药业股份有限公司生产)与参比制剂氯雷他定片(开瑞坦®,规格:10 mg,拜耳医药(上海)有限公司持证)在健康成年试验参与者体内的药代动力学,评价空腹状态下口服两种制剂的生物等效性。次要研究目的:评估受试制剂氯雷他定片(规格:10 mg)和参比制剂氯雷他定片(开瑞坦®,规格:10 mg)在健康成年试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation loratadine tablets (10 mg, manufactured by Chenxin Pharmaceutical Co., Ltd.) and the reference formulation loratadine tablets (Claritin®, 10 mg, certified by Bayer Pharmaceuticals (Shanghai) Co., Ltd.) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary objective: To assess the safety of the test formulation loratadine tablets (10 mg) and the reference formulation loratadine tablets (Claritin®, 10 mg) in healthy adult participants.