/ 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 after a single oral dose in the fed state
主要目的:考察中国健康男性受试者在餐后条件下单次口服由海南卓泰制药有限公司持有,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 Hainan Zhuotai Pharmaceutical 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 meal 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 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海南卓泰制药有限公司持有的阿帕他胺片(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) held by Hainan Zhuotai Pharmaceutical Co., Ltd. and apalutamide tablets (trade name: Erleada®/Ansenke®, specification: 60 mg) held 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 a single oral dose of apalutamide tablets test preparation and reference preparation in healthy Chinese male subjects.
100 Clinical Results associated with Hainan Zhuotai Pharmaceutical Co Ltd.
0 Patents (Medical) associated with Hainan Zhuotai Pharmaceutical Co Ltd.
100 Deals associated with Hainan Zhuotai Pharmaceutical Co Ltd.
100 Translational Medicine associated with Hainan Zhuotai Pharmaceutical Co Ltd.