/ Not yet recruitingNot Applicable 奥美拉唑肠溶胶囊在中国健康受试者中随机、开放、两制 剂、单次给药、空腹两周期两序列交叉生物等效性研究
[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence crossover bioequivalence study of omeprazole enteric-coated capsules in Chinese healthy subjects
主要目的：以江苏长江药业有限公司生产、南京润瞳畅达医药科技有限公司提供的奥美拉唑肠溶胶囊为受试制剂，按生物等效性研究的有关规定，与Pharmaco（NZ）Ltd公司生产的奥美拉唑肠溶胶囊（商品名：Losec®，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。
次要目的：观察受试制剂奥美拉唑肠溶胶囊和参比制剂奥美拉唑肠溶胶囊（Losec®）在健康受试者中的安全性。
[Translation] Main purpose: Omeprazole enteric-coated capsules produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. and provided by Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence studies, the absorption rate and degree of Omeprazole enteric-coated capsules (trade name: Losec®, reference preparation) produced by Pharmaco (NZ) Ltd were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Omeprazole enteric-coated capsules and the reference preparation Omeprazole enteric-coated capsules (Losec®) in healthy subjects.
/ Not yet recruitingNot Applicable 奥美拉唑肠溶胶囊在中国健康受试者中随机、开放、两制 剂、单次给药、空腹两周期两序列交叉生物等效性研究
[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence crossover bioequivalence study of omeprazole enteric-coated capsules in Chinese healthy subjects
主要目的：以江苏长江药业有限公司生产、南京润瞳畅达医药科技有限公司提供的奥美拉唑肠溶胶囊为受试制剂，按生物等效性研究的有关规定，与Pharmaco（NZ）Ltd公司生产的奥美拉唑肠溶胶囊（商品名：Losec®，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。
次要目的：观察受试制剂奥美拉唑肠溶胶囊和参比制剂奥美拉唑肠溶胶囊（Losec®）在健康受试者中的安全性。
[Translation] Main purpose: Omeprazole enteric-coated capsules produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. and provided by Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence studies, the absorption rate and degree of Omeprazole enteric-coated capsules (trade name: Losec®, reference preparation) produced by Pharmaco (NZ) Ltd were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Omeprazole enteric-coated capsules and the reference preparation Omeprazole enteric-coated capsules (Losec®) in healthy subjects.
/ Not yet recruitingNot Applicable 奥美拉唑肠溶胶囊在中国健康受试者中随机、开放、两制 剂、单次给药、餐后四周期两序列完全重复交叉生物等效性研究
[Translation] A randomized, open-label, two-formulation, single-dose, four-cycle, two-sequence, complete repeat crossover bioequivalence study of omeprazole enteric-coated capsules in Chinese healthy subjects
主要目的：以江苏长江药业有限公司生产、南京润瞳畅达医药科技有限公司提供的奥美拉唑肠溶胶囊为受试制剂，按生物等效性研究的有关规定，与Pharmaco（NZ）Ltd公司生产的奥美拉唑肠溶胶囊（商品名：Losec®，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。
次要目的：观察受试制剂奥美拉唑肠溶胶囊和参比制剂奥美拉唑肠溶胶囊（Losec®）在健康受试者中的安全性。
[Translation] Main purpose: Omeprazole enteric-coated capsules produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. and provided by Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence studies, the absorption rate and degree of Omeprazole enteric-coated capsules (trade name: Losec®, reference preparation) produced by Pharmaco (NZ) Ltd were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Omeprazole enteric-coated capsules and the reference preparation Omeprazole enteric-coated capsules (Losec®) in healthy subjects.
100 Clinical Results associated with Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd.
100 Deals associated with Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Nanjing Runtong Changda Pharmaceutical Technology Co., Ltd.
