[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover controlled trial was conducted to evaluate the bioequivalence of a single oral dose of metoclopramide tablets in Chinese healthy subjects in the fasting and fed state.
主要目的:以华诺医药(广州)有限公司提供的甲氧氯普胺片为受试制剂,按生物等效性试验的有关规定,与ANI Pharmaceuticals, Inc生产并持证的甲氧氯普胺片(商品名:REGLAN®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main objective: To compare the absorption rate and extent of metoclopramide tablets provided by Huanuo Pharmaceuticals (Guangzhou) Co., Ltd. with metoclopramide tablets (trade name: REGLAN®, reference preparation) produced and certified by ANI Pharmaceuticals, Inc. in healthy human bodies using metoclopramide tablets as the test preparation according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.