[Translation] A single-center, randomized, open-label, two-period, double-sequential, double-crossover bioequivalence pilot study to evaluate the efficacy of a single oral dose of domperidone tablets in healthy Chinese subjects in the fasting state
研究在空腹状态下健康受试者单次口服江西捷众制药有限公司生产的多潘立酮片(受试制剂T,规格:10mg/片)和西安杨森制药有限公司生产的多潘立酮片(商品名吗丁啉®,参比制剂R,规格:10mg/片)的血药浓度经时过程,验证分析方法,评估变异程度,优化采样时间,以及获得其他相关信息。
[Translation] The purpose of this study was to study the time course of blood drug concentration of domperidone tablets (test preparation T, specification: 10 mg/tablet) produced by Jiangxi Jiezhong Pharmaceutical Co., Ltd. and domperidone tablets (trade name: Motilium®, reference preparation R, specification: 10 mg/tablet) produced by Xi'an Janssen Pharmaceutical Co., Ltd. in healthy subjects after a single oral administration in the fasting state, to verify the analytical method, evaluate the degree of variation, optimize the sampling time, and obtain other relevant information.