|
MechanismProton pump inhibitors |
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date31 Dec 1988 |
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] Bioequivalence study of a single oral dose of omeprazole enteric-coated capsules in Chinese healthy volunteers under fasting and fed 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] To investigate whether there are differences in the extent and rate of absorption of the test preparation Omeprazole Enteric-coated Capsules (Hong Kong Zhengmei Pharmaceutical Co., Ltd., specification: 20 mg) and the reference preparation Omeprazole Enteric-coated Capsules (trade name: Losec®; Astrazeneca Limited, specification: 20 mg) taken orally on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Zhuhai Youbang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhuhai Youbang Pharmaceutical Co., Ltd.
100 Deals associated with Zhuhai Youbang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhuhai Youbang Pharmaceutical Co., Ltd.