/ Active, not recruitingNot Applicable [Translation] Human bioequivalence study of levamlodipine besylate tablets
主要目的：
比较空腹和餐后给药条件下新石阳光药业（河北）有限公司提供的苯磺酸左氨氯地平片（规格：5 mg（按左氨氯地平计））与晖致制药（大连）有限公司持证的苯磺酸氨氯地平片（商品名：络活喜®/Norvasc®；规格：10 mg（按氨氯地平计））在中国健康人群吸收程度和吸收速度的差异。
次要目的：
评价空腹及餐后条件下，新石阳光药业（河北）有限公司提供的苯磺酸左氨氯地平片（规格：5 mg（按左氨氯地平计））与晖致制药（大连）有限公司持证的苯磺酸氨氯地平片（商品名：络活喜®/Norvasc®；规格：10 mg（按氨氯地平计））在健康研究参与者体内的安全性。
[Translation] Primary Objective: To compare the absorption extent and rate of absorption of levamlodipine besylate tablets (5 mg, calculated as levamlodipine) supplied by Xinshi Sunshine Pharmaceutical (Hebei) Co., Ltd., and amlodipine besylate tablets (trade name: Norvasc®; strength: 10 mg, calculated as amlodipine) certified by Huizhi Pharmaceutical (Dalian) Co., Ltd., in a healthy Chinese population under fasting and postprandial administration conditions.
Secondary Objective: To evaluate the safety of levamlodipine besylate tablets (5 mg, calculated as levamlodipine) supplied by Xinshi Sunshine Pharmaceutical (Hebei) Co., Ltd., and amlodipine besylate tablets (trade name: Norvasc®; strength: 10 mg, calculated as amlodipine) certified by Huizhi Pharmaceutical (Dalian) Co., Ltd., in healthy study participants under fasting and postprandial administration conditions.
/ Not yet recruitingNot Applicable 多替诺雷片在健康试验参与者中随机、开放、两制剂、单次给药、两周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover bioequivalence study of dotenoradine tablets in healthy trial participants.
主要目的：以新石阳光药业（河北）有限公司研制的多替诺雷片为受试制剂，以株式会社富士薬品持证的多替诺雷片（商品名：URECE®）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。
次要目的：评价中国健康试验参与者单次空腹/餐后口服多替诺雷片受试制剂和参比制剂后的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetic parameters and relative bioavailability of dotenorazole tablets (developed by Xinshi Sunshine Pharmaceutical (Hebei) Co., Ltd.) under fasting and postprandial administrations, using dortenorazole tablets (trade name: URECE®) certified by Fuji Pharmaceutical Co., Ltd. as the test formulation and dortenorazole tablets (trade name: URECE®) as the reference formulation, and to evaluate the bioequivalence of the two formulations after a single oral administration under fasting and postprandial conditions.
Secondary Objective: To evaluate the safety of single oral administration of dortenorazole tablets (test and reference formulations) to Chinese healthy participants in a health trial, under fasting/postprandial conditions.
/ Not yet recruitingNot Applicable 美阿沙坦钾片在成年健康试验参与者中的一项单中心、随机、开放、空腹和餐后条件下单次给药、两制剂、两周期交叉的生物等效性试验
[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-formulation, two-period crossover bioequivalence study of measartan potassium tablets in healthy adult participants.
主要研究目的：考察空腹及餐后条件下单次口服80mg受试制剂美阿沙坦钾片和参比制剂美阿沙坦钾片，在中国成年健康试验参与者体内的药代动力学特征，评估空腹及餐后条件下分别口服两种制剂的生物等效性。
次要研究目的：评价受试制剂和参比制剂单次口服80mg在中国成年健康试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of 80 mg of the test formulation measartan potassium tablets and the reference formulation measartan potassium tablets in healthy adult participants in China under fasting and postprandial conditions, and to assess the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To evaluate the safety of a single oral dose of 80 mg of the test and reference formulations in healthy adult participants in China.
100 Clinical Results associated with Xinshi Sunshine Pharmaceutical(Hebei) Co., Ltd
0 Patents (Medical) associated with Xinshi Sunshine Pharmaceutical(Hebei) Co., Ltd
100 Deals associated with Xinshi Sunshine Pharmaceutical(Hebei) Co., Ltd
100 Translational Medicine associated with Xinshi Sunshine Pharmaceutical(Hebei) Co., Ltd
