/ CompletedNot Applicable [Translation] Bioequivalence study of amlodipine besylate tablets in healthy volunteers
观察苯磺酸左氨氯地平片在中国健康受试者中单次口服给药后的左旋氨氯地平体内动力学过程,估算相应的药代动力学参数,并以辉瑞制药有限公司生产的苯磺酸氨氯地平片(络活喜®)为参比制剂,进行生物等效性评价。
[Translation] To observe the in vivo kinetics of levoamlodipine besylate tablets after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and conduct bioequivalence evaluation using amlodipine besylate tablets (Norvasc®) produced by Pfizer as the reference preparation.
/ CompletedNot Applicable 开放随机单中心四周期完全重复单次口服给药交叉设计评价盐酸非索非那定片受试制剂与参比制剂在健康受试者的生物等效性研究
[Translation] An open randomized single-center four-period completely repeated single oral administration crossover design to evaluate the bioequivalence of the test preparation and the reference preparation of fexofenadine hydrochloride tablets in healthy volunteers
研究空腹和餐后状态下单次口服受试制剂盐酸非索非那定片(规格60mg)与参比制剂盐酸非索非那定片Allegra(规格60mg;Sanofi K.K.)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。 次要目的:研究受试制剂盐酸非索非那定片(规格60mg)和参比制剂盐酸非索非那定片(Allegra,规格60mg)在健康成年受试者中的安全性
[Translation] To investigate the pharmacokinetics of a single oral dose of the test preparation fexofenadine hydrochloride tablets (60 mg) and the reference preparation fexofenadine hydrochloride tablets Allegra (60 mg; Sanofi K.K.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To investigate the safety of the test preparation fexofenadine hydrochloride tablets (60 mg) and the reference preparation fexofenadine hydrochloride tablets (Allegra, 60 mg) in healthy adult subjects
/ Not yet recruitingNot Applicable 瑞格列奈片在健康受试者中单中心、随机、开放、单剂量空腹和餐后状态下的生物等效性试验
[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of repaglinide tablets in healthy subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下,四川省旭晖制药有限公司提供的瑞格列奈片(1mg)与Novo Nordisk A/S持证的瑞格列奈片(1mg,商品名:诺和龙®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,四川省旭晖制药有限公司提供的瑞格列奈片(1mg)与Novo Nordisk A/S持证的瑞格列奈片(1mg,商品名:诺和龙®)的安全性。
[Translation] Main purpose
To compare the differences in the extent and rate of absorption of repaglinide tablets (1 mg) provided by Sichuan Xuhui Pharmaceutical Co., Ltd. and repaglinide tablets (1 mg, trade name: Novolong®) licensed by Novo Nordisk A/S in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of repaglinide tablets (1 mg) provided by Sichuan Xuhui Pharmaceutical Co., Ltd. and repaglinide tablets (1 mg, trade name: Novolong®) licensed by Novo Nordisk A/S under fasting and postprandial administration conditions.
100 Clinical Results associated with Sichuan Xuhui Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Sichuan Xuhui Pharmaceutical Co., Ltd.
100 Deals associated with Sichuan Xuhui Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Sichuan Xuhui Pharmaceutical Co., Ltd.