苯磺酸左氨氯地平片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹及餐后状态下的生物等效性研究
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of levamlodipine besylate tablets in healthy subjects under fasting and fed conditions
主要目的:比较空腹及餐后给药条件下,江西仁齐制药有限公司生产的苯磺酸左氨氯地平片(2.5mg/片)与辉瑞制药有限公司持证的苯磺酸氨氯地平片(5mg/片,商品名:络活喜®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹及餐后给药条件下,江西仁齐制药有限公司生产的苯磺酸左氨氯地平片(2.5mg/片)与辉瑞制药有限公司持证的苯磺酸氨氯地平片(5mg/片,商品名:络活喜®)的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and speed of levamlodipine besylate tablets (2.5 mg/tablet) produced by Jiangxi Renqi Pharmaceutical Co., Ltd. and amlodipine besylate tablets (5 mg/tablet, trade name: Norvasc®) certified by Pfizer Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of levamlodipine besylate tablets (2.5 mg/tablet) produced by Jiangxi Renqi Pharmaceutical Co., Ltd. and amlodipine besylate tablets (5 mg/tablet, trade name: Norvasc®) certified by Pfizer Pharmaceuticals Co., Ltd. under fasting and postprandial administration conditions.
/ CompletedNot Applicable 盐酸达泊西汀片在健康受试者中单中心、开放、均衡、 随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of dapoxetine hydrochloride tablets in healthy subjects under fasting and fed conditions
主要目的:比较空腹及餐后给药条件下,江西仁齐制药有限公司提供的盐酸达泊西汀 片(30mg/片)与Berlin-Chemie AG持证的盐酸达泊西汀片(30mg/片,商品名: Priligy®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹及餐后给药条件下,江西仁齐制药有限公司提供的盐酸达泊西汀片(30mg/片)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of dapoxetine hydrochloride tablets (30 mg/tablet) provided by Jiangxi Renqi Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets (30 mg/tablet, trade name: Priligy®) certified by Berlin-Chemie AG in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of dapoxetine hydrochloride tablets (30 mg/tablet) provided by Jiangxi Renqi Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions.
/ CompletedNot Applicable 孟鲁司特钠颗粒在中国健康受试者中随机、开放、单次给药、两制剂、两周期、双交叉、空腹和餐后生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, two-period, double-crossover, fasting and fed bioequivalence study of montelukast sodium granules in Chinese healthy subjects
主要研究目的:以江西仁齐制药有限公司生产的孟鲁司特钠颗粒(0.5g:4mg(以孟鲁司特计))为受试制剂(T),按有关生物等效性试验的规定,以Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc生产的孟鲁司特钠颗粒(0.5g:4mg(以孟鲁司特计),顺尔宁®)为参比制剂(R)进行生物等效性试验。
次要研究目的:观察受试制剂和参比制剂孟鲁司特钠颗粒在健康受试者中的安全性。
[Translation] The main purpose of the study was to use the Montelukast Sodium Granules (0.5g:4mg (in terms of Montelukast)) produced by Jiangxi Renqi Pharmaceutical Co., Ltd. as the test preparation (T), and the Montelukast Sodium Granules (0.5g:4mg (in terms of Montelukast), Singulair®) produced by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. as the reference preparation (R) for bioequivalence study according to the relevant provisions of bioequivalence study.
Secondary purpose of the study was to observe the safety of the test preparation and the reference preparation Montelukast Sodium Granules in healthy subjects.
100 Clinical Results associated with Nanchang Weiyang Biochemical Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Nanchang Weiyang Biochemical Pharmaceutical Co., Ltd.
100 Deals associated with Nanchang Weiyang Biochemical Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Nanchang Weiyang Biochemical Pharmaceutical Co., Ltd.