中国健康受试者空腹及餐后状态下单次口服奥美拉唑肠溶胶囊的人体生物等效性试验
[Translation] Human bioequivalence trial of single oral administration of omeprazole enteric-coated capsules in Chinese healthy subjects under fasting and postprandial conditions
研究健康受试者空腹及餐后单次口服受试制剂奥美拉唑肠溶胶囊(香港正美药品有限公司,规格:20mg)与参比制剂奥美拉唑肠溶胶囊(商品名:Losec®;Astrazeneca Limited,规格:20mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后状态下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Study healthy subjects' fasting and single-dose oral administration after meals of the test preparation omeprazole enteric-coated capsules (Hong Kong Zhengmei Pharmaceutical Co., Ltd., specification: 20mg) and the reference preparation omeprazole enteric-coated capsules (trade name: Losec® ; Astrazeneca Limited, specification: 20mg), whether there is any difference in the degree and speed of absorption, evaluate the bioequivalence of the test preparation and the reference preparation when administered in the fasting and postprandial state, and observe the test preparation and the reference preparation Safety in healthy subjects.
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