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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date29 Apr 2019 |
/ Active, not recruitingNot Applicable 健康受试者空腹(苹果酱撒布)条件下口服艾司奥美拉唑镁肠溶胶囊20mg受试制剂和参比制剂的随机、开放、交叉生物等效性试验
[Translation] A randomized, open-label, crossover bioequivalence study of the test and reference formulations of esomeprazole magnesium enteric-coated capsules 20 mg in healthy subjects on an empty stomach (apple sauce spread)
评价健康受试者在空腹(苹果酱撒布)条件下单剂量服用厦门力卓药业有限公司的艾司奥美拉唑镁肠溶胶囊20 mg(受试制剂)与Astrazeneca Pharmaceuticals Lp的艾司奥美拉唑镁肠溶胶囊20 mg(参比制剂)的生物等效性以及安全性
[Translation] To evaluate the bioequivalence and safety of a single dose of esomeprazole magnesium enteric-coated capsules 20 mg (test formulation) from Xiamen Lizhuo Pharmaceutical Co., Ltd. and esomeprazole magnesium enteric-coated capsules 20 mg (reference formulation) from Astrazeneca Pharmaceuticals Lp in healthy subjects under fasting (apple sauce spread) conditions.
/ CompletedNot Applicable 健康受试者在餐后条件下口服艾司奥美拉唑镁肠溶胶囊20 mg受试制剂和参比制剂的随机、开放、交叉生物等效性试验
[Translation] A randomized, open-label, crossover bioequivalence study of the test and reference formulations of esomeprazole magnesium enteric-coated capsules 20 mg in healthy subjects after oral administration
评价健康受试者在餐后条件下单剂量服用厦门力卓药业有限公司的艾司奥美拉唑镁肠溶胶囊20 mg(受试制剂)与Astrazeneca Pharmaceuticals Lp的艾司奥美拉唑镁肠溶胶囊20 mg(参比制剂)的生物等效性以及安全性。
[Translation] To evaluate the bioequivalence and safety of single-dose esomeprazole magnesium enteric-coated capsules 20 mg (test preparation) produced by Xiamen Lizhuo Pharmaceutical Co., Ltd. and esomeprazole magnesium enteric-coated capsules 20 mg (reference preparation) produced by Astrazeneca Pharmaceuticals Lp in healthy subjects after taking a single dose under fed conditions.
健康受试者在空腹条件下口服艾司奥美拉唑镁肠溶胶囊20 mg受试制剂和参比制剂的随机、开放、交叉生物等效性试验
[Translation] A randomized, open-label, crossover bioequivalence study of the test and reference formulations of esomeprazole magnesium enteric-coated capsules 20 mg in healthy subjects under fasting conditions
评价健康受试者在空腹条件下单剂量服用厦门力卓药业有限公司的艾司奥美拉唑镁肠溶胶囊20 mg(受试制剂)与Astrazeneca Pharmaceuticals Lp的艾司奥美拉唑镁肠溶胶囊20 mg(参比制剂)的生物等效性以及安全性。
[Translation] To evaluate the bioequivalence and safety of single-dose esomeprazole magnesium enteric-coated capsules 20 mg (test preparation) produced by Xiamen Lizhuo Pharmaceutical Co., Ltd. and esomeprazole magnesium enteric-coated capsules 20 mg (reference preparation) produced by Astrazeneca Pharmaceuticals Lp in healthy subjects under fasting conditions.
100 Clinical Results associated with Lizhuo Pharmaceutical (Xiamen) Co., Ltd.
0 Patents (Medical) associated with Lizhuo Pharmaceutical (Xiamen) Co., Ltd.
100 Deals associated with Lizhuo Pharmaceutical (Xiamen) Co., Ltd.
100 Translational Medicine associated with Lizhuo Pharmaceutical (Xiamen) Co., Ltd.