/ Not yet recruitingNot Applicable 孟鲁司特钠颗粒在健康的研究参与者中单中心、开放、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, randomized, single-dose, two-period, double-crossover bioequivalence study of montelukast sodium granules in healthy study participants in the fasting and fed states
主要目的:
空腹和餐后给药条件下,比较广州博济生物医药科技园有限公司生产的孟鲁司特钠颗粒(0.5g:4mg)与Merck Sharp & Dohme Corp持证的孟鲁司特钠颗粒(0.5g:4mg,商品名:顺尔宁®)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:
评价空腹和餐后给药条件下,受试制剂孟鲁司特钠颗粒(0.5g:4mg)在健康的研究参与者中的安全性。
[Translation] Primary objective:
To compare the differences in the extent and rate of absorption of montelukast sodium granules (0.5g:4mg) produced by Guangzhou Boji Biomedical Science and Technology Park Co., Ltd. and montelukast sodium granules (0.5g:4mg, trade name: Singulair®) certified by Merck Sharp & Dohme Corp in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective:
To evaluate the safety of the test formulation montelukast sodium granules (0.5g:4mg) in healthy study participants under fasting and postprandial administration conditions.
/ Not yet recruitingNot Applicable 氨甲环酸片在中国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试验
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of tranexamic acid tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:空腹和餐后给药条件下,比较广州华圣制药有限公司提供的氨甲环酸片(规格:0.5 g)与CMIC CMO CO., LTD. Shizuoka Plant生产的氨甲环酸片(妥塞敏®,规格:0.5 g)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:评价空腹和餐后给药条件下,广州华圣制药有限公司提供的氨甲环酸片(规格:0.5 g)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of tranexamic acid tablets (specification: 0.5 g) provided by Guangzhou Huasheng Pharmaceutical Co., Ltd. and tranexamic acid tablets (Tosamine®, specification: 0.5 g) produced by CMIC CMO CO., LTD. Shizuoka Plant in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of tranexamic acid tablets (specification: 0.5 g) provided by Guangzhou Huasheng Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions.
100 Clinical Results associated with Guangzhou Boji Biomedical Science Park Co., Ltd.
0 Patents (Medical) associated with Guangzhou Boji Biomedical Science Park Co., Ltd.
100 Deals associated with Guangzhou Boji Biomedical Science Park Co., Ltd.
100 Translational Medicine associated with Guangzhou Boji Biomedical Science Park Co., Ltd.