[Translation] A single-center, randomized, open-label, single-dose, four-period, complete repeated crossover, fasting and fed bioequivalence study of loratadine tablets in participants of the China Health Study
主要研究目的:以拜耳医药(上海)有限公司持证的氯雷他定片(商品名:开瑞坦®,规格:10 mg)为参比制剂,以山东良福制药有限公司生产的氯雷他定片(规格:10 mg)为受试制剂,通过单中心、随机、开放、单次给药、四周期、完全重复交叉的空腹/餐后状态下的临床研究来评价两种制剂的人体生物等效性。
次要研究目的:评价中国健康研究参与者单次空腹/餐后口服受试制剂和参比制剂后的安全性。
[Translation] The main purpose of the study is to use the loratadine tablets (trade name: Claritin®, specification: 10 mg) certified by Bayer Pharmaceuticals (Shanghai) Co., Ltd. as the reference preparation and the loratadine tablets (specification: 10 mg) produced by Shandong Liangfu Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, four-cycle, completely repeated crossover clinical study in the fasting/postprandial state.
Secondary purpose of the study: to evaluate the safety of the test preparation and reference preparation after a single fasting/postprandial oral administration in the Chinese Health Study participants.