/ Not yet recruitingNot 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.
/ CompletedNot Applicable [Translation] Bioequivalence study of baricitinib tablets in humans under fasting and fed conditions
本研究考察健康男性和女性受试者在空腹及餐后条件下,单次口服由安徽泰恩康制药有限公司提供的巴瑞替尼片(受试制剂,规格:2mg)与相同条件下单次口服由Eli Lilly Nederland B.V.持证的巴瑞替尼片(参比制剂,商品名:艾乐明®,规格:2mg)的药动学特征,评价两制剂间的生物等效性及安全性,为该受试制剂的注册申请提供依据。
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of baricitinib tablets (test preparation, strength: 2 mg) provided by Anhui Taienkang Pharmaceutical Co., Ltd. and a single oral dose of baricitinib tablets (reference preparation, trade name: Ailemin®, strength: 2 mg) certified by Eli Lilly Nederland B.V. under the same conditions in healthy male and female subjects under fasting and postprandial conditions, evaluated the bioequivalence and safety of the two preparations, and provided a basis for the registration application of the test preparation.
复方硫酸钠片用于结肠镜检查前肠道准备的有效性和安全性的多中心、随机、单盲、阳性药平行对照的临床试验
[Translation] A multicenter, randomized, single-blind, positive-drug parallel-controlled clinical trial on the effectiveness and safety of compound sodium sulfate tablets for bowel preparation before colonoscopy
以复方聚乙二醇电解质散为对照,评价复方硫酸钠片用于结肠镜检查前肠道准备的有效性和安全性。
[Translation] To evaluate the effectiveness and safety of compound sodium sulfate tablets for bowel preparation before colonoscopy, using compound polyethylene glycol electrolyte powder as a control.
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.