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/ CompletedNot Applicable [Translation] Bioequivalence study of metoclopramide tablets (10 mg) in healthy volunteers
主要目的:
本研究以卡文迪许(泰州)药业有限公司持有,江苏悦兴药业有限公司生产的甲氧氯普胺片(规格:10 mg)为受试制剂,按生物等效性研究有关规定,以ANI PHARMACEUTICALS INC持有的甲氧氯普胺片(规格:10 mg,商品名:REGLAN®)为参比制剂,评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要目的:
观察受试制剂甲氧氯普胺片和参比制剂甲氧氯普胺片(REGLAN®)在健康受试者中的安全性。
[Translation] Main purpose:
This study used metoclopramide tablets (specification: 10 mg) owned by Cavendish (Taizhou) Pharmaceutical Co., Ltd. and produced by Jiangsu Yuexing Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, metoclopramide tablets (specification: 10 mg, trade name: REGLAN®) owned by ANI PHARMACEUTICALS INC were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions.
Secondary purpose:
Observe the safety of the test preparation metoclopramide tablets and the reference preparation metoclopramide tablets (REGLAN®) in healthy subjects.
100 Clinical Results associated with Cavendish (Taizhou) Pharmaceutical Co., Ltd.
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