/ CompletedNot Applicable 地诺孕素片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉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 dienogest tablets in healthy subjects under the fed state
主要目的
比较餐后给药条件下,安徽泰恩康制药有限公司提供的地诺孕素片(2mg)与Jenapharm GmbH & Co. KG持证的地诺孕素片(2mg,商品名:唯散宁®)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
评价餐后给药条件下,安徽泰恩康制药有限公司提供的地诺孕素片(2mg)与Jenapharm GmbH & Co. KG持证的地诺孕素片(2mg,商品名:唯散宁®)的安全性。
[Translation] Main purpose
To compare the differences in absorption extent and speed of dienogest tablets (2 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and dienogest tablets (2 mg, trade name: Visanning®) certified by Jenapharm GmbH & Co. KG in healthy adults under the condition of postprandial administration, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of dienogest tablets (2 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and dienogest tablets (2 mg, trade name: Visanning®) certified by Jenapharm GmbH & Co. KG under the condition of postprandial administration.
/ CompletedNot Applicable 甲磺酸沙非胺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 safinamide mesylate tablets in healthy subjects under fasting conditions
主要目的 比较空腹给药条件下,安徽泰恩康制药有限公司提供的甲磺酸沙非胺片(100mg) 与Zambon S.p.A.持证的甲磺酸沙非胺片(100mg;商品名:Xadago ®)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 评价空腹给药条件下,安徽泰恩康制药有限公司提供的甲磺酸沙非胺片(100mg) 与Zambon S.p.A.持证的甲磺酸沙非胺片(100mg;商品名:Xadago ®)的安全性。
[Translation] Primary objective To compare the differences in the extent and rate of absorption of safinamide mesylate tablets (100 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and safinamide mesylate tablets (100 mg; trade name: Xadago ®) licensed by Zambon S.p.A. in healthy adults under fasting conditions, and to evaluate their bioequivalence. Secondary objective To evaluate the safety of safinamide mesylate tablets (100 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and safinamide mesylate tablets (100 mg; trade name: Xadago ®) licensed by Zambon S.p.A. under fasting conditions.
/ CompletedNot Applicable 地诺孕素片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹状态下的
生物等效性试验
[Translation] A single-center, open, randomized, single-dose, two-cycle, double-crossover bioequivalence study of dienogest tablets in healthy subjects under fasting conditions
主要目的
比较空腹给药条件下,安徽泰恩康制药有限公司提供的地诺孕素片(2mg)与Jenapharm GmbH & Co. KG持证的地诺孕素片(2mg,商品名:唯散宁®)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
评价空腹给药条件下,安徽泰恩康制药有限公司提供的地诺孕素片(2mg)与Jenapharm GmbH & Co. KG持证的地诺孕素片(2mg,商品名:唯散宁®)的安全性。
[Translation] Main purpose
To compare the differences in the extent and rate of absorption of dienogest tablets (2 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and dienogest tablets (2 mg, trade name: Visanning®) certified by Jenapharm GmbH & Co. KG in healthy adults under fasting conditions, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of dienogest tablets (2 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and dienogest tablets (2 mg, trade name: Visanning®) certified by Jenapharm GmbH & Co. KG under fasting conditions.
100 Clinical Results associated with Anhui Taienkang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Anhui Taienkang Pharmaceutical Co., Ltd.
100 Deals associated with Anhui Taienkang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Anhui Taienkang Pharmaceutical Co., Ltd.