/ Not yet recruitingNot Applicable 一项在中国健康受试者中评估阿帕他胺片的空腹、餐后生物等效性研究
[Translation] A fasting and fed bioequivalence study of apalutamide tablets in healthy Chinese subjects
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无锡紫杉药业股份有限公司持有,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 Wuxi Taxus 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 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 after a single oral dose in healthy Chinese male subjects.
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