/ Not yet recruitingNot Applicable 一项随机、开放、两序列交叉设计,评价健康男性受试者空腹/餐后状态下单次口服阿帕他胺片的生物等效性试验
[Translation] A randomized, open-label, two-sequence crossover design study to evaluate the bioequivalence of apalutamide tablets in healthy male subjects in the fasting/fed state after a single oral dose
主要目的:考察中国健康男性受试者在空腹/餐后条件下单次口服由山东新鲁医药科技有限公司持有,上海创诺制药有限公司生产的阿帕他胺片(规格:60mg)与Janssen-Cilag International NV持证的阿帕他胺片(商品名:Erleada®/安森珂®,规格:60mg)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服阿帕他胺片受试制剂及参比制剂在中国健康男性受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of apalutamide tablets (specification: 60 mg) owned by Shandong Xinlu Pharmaceutical Technology Co., Ltd. and produced by Shanghai Chuangnuo Pharmaceutical Co., Ltd. and apalutamide tablets (trade name: Erleada®/Ansenke®, specification: 60 mg) licensed by Janssen-Cilag International NV in healthy Chinese male subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test and reference preparations of apalutamide tablets taken orally in healthy Chinese male subjects.
/ CompletedNot Applicable 艾拉莫德片在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A single-dose bioequivalence clinical trial of iguratimod tablets in healthy Chinese subjects
主要目的:以持证商为海南先声药业有限公司的艾拉莫德片(商品名:艾得辛,规格:25mg)为参比制剂,以山东新鲁医药科技有限公司研发的艾拉莫德片(规格:25mg)为受试制剂,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the reference preparation of Aguratimod tablets (trade name: Edexin, specification: 25 mg) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation and the test preparation of Aguratimod tablets (specification: 25 mg) developed by Shandong Xinlu Pharmaceutical Technology Co., Ltd. as the test preparation.
Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Shandong Xinlu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shandong Xinlu Pharmaceutical Co., Ltd.
100 Deals associated with Shandong Xinlu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shandong Xinlu Pharmaceutical Co., Ltd.