阿帕他胺片(60 mg)随机、开放、两周期、两交叉单次给药空腹/餐后状态下在健康男性受试者中的生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of apalutamide tablets (60 mg) in healthy male subjects under fasting/fed conditions
主要试验目的:在健康男性受试者中于空腹/餐后条件下,评价受试制剂阿帕他胺片(规格:60 mg,生产商:江苏利泰尔药业有限公司)和Janssen-Cilag International NV为持证商的参比制剂阿帕他胺片(安森珂®,规格:60 mg)的生物等效性。
[Translation] The main purpose of the study is to evaluate the bioequivalence of the test preparation apalutamide tablets (strength: 60 mg, manufacturer: Jiangsu Litaier Pharmaceutical Co., Ltd.) and the reference preparation apalutamide tablets (Ansenke®, strength: 60 mg) of which Janssen-Cilag International NV is the licensee in healthy male subjects under fasting/postprandial conditions.
醋酸去氨加压素片(0.1 mg)空腹/餐后状态下在健康受试者中的生物等效性试验
[Translation] Bioequivalence study of desmopressin acetate tablets (0.1 mg) in healthy volunteers in fasting/fed state
主要试验目的:在健康男性与女性受试者中于空腹/餐后条件下,评价受试制剂醋酸去氨加压素片(规格:0.1 mg,生产商:江苏利泰尔药业有限公司)和辉凌国际制药(瑞士)有限公司生产的参比制剂醋酸去氨加压素片(弥凝®,规格:0.1 mg)的生物等效性。
[Translation] The main purpose of the study is to evaluate the bioequivalence of the test preparation, desmopressin acetate tablets (specification: 0.1 mg, manufacturer: Jiangsu Litaier Pharmaceutical Co., Ltd.) and the reference preparation, desmopressin acetate tablets (Mining®, specification: 0.1 mg) produced by Ferring International Pharmaceuticals (Switzerland) Co., Ltd., under fasting/postprandial conditions in healthy male and female subjects.
盐酸决奈达隆片(400mg)随机、开放、两周期、两交叉单次空腹/餐后状态下在健康男性受试者中的生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of dronedarone hydrochloride tablets (400 mg) in healthy male subjects in the fasting/fed state
主要目的:
在健康男性受试者中于空腹/餐后条件下评价受试制剂和参比制剂的生物等效性。
次要目的:
观察受试制剂与参比制剂在健康男性受试者中的安全性。
[Translation] Primary objective:
To evaluate the bioequivalence of the test formulation and the reference formulation in healthy male subjects under fasting/fed conditions.
Secondary objective:
To observe the safety of the test formulation and the reference formulation in healthy male subjects.
100 Clinical Results associated with Jiangsu Litaier Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Litaier Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Litaier Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Litaier Pharmaceutical Co., Ltd.