/ CompletedNot Applicable 评估受试制剂盐酸达泊西汀片(规格:60mg)与参比制剂(Priligy®)(规格:60mg)在健康成年男性参与者空腹和餐后状态下的单中心、开放、随机、单剂量、交叉生物等效性试验
[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence trial evaluating the test formulation dapoxetine hydrochloride tablets (60 mg) versus the reference formulation (Priligy®) (60 mg) in healthy adult male participants under fasting and postprandial conditions.
主要试验目的:研究空腹和餐后状态下单次口服受试制剂盐酸达泊西汀片(规格:60 mg,四川依科制药有限公司生产)与参比制剂盐酸达泊西汀片(Priligy®,规格:60 mg;Menarini-Von Heyden GmbH生产)在健康男性参与者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂盐酸达泊西汀片(规格:60 mg)和参比制剂盐酸达泊西汀片(Priligy®)(规格:60 mg)在健康男性参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of the test formulation dapoxetine hydrochloride tablets (60 mg, manufactured by Sichuan Yike Pharmaceutical Co., Ltd.) and the reference formulation dapoxetine hydrochloride tablets (Priligy®, 60 mg; manufactured by Menarini-Von Heyden GmbH) in healthy male participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To investigate the safety of the test formulation dapoxetine hydrochloride tablets (60 mg) and the reference formulation dapoxetine hydrochloride tablets (Priligy®) (60 mg) in healthy male participants.
/ CompletedNot Applicable 枸橼酸西地那非片在健康男性受试者中的单剂量、随机、开放、交叉、两制剂、两周期空腹和餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover, two-dose, two-period fasting and fed bioequivalence study of sildenafil citrate tablets in healthy male volunteers
主要目的:以四川依科制药有限公司的枸橼酸西地那非片(T,规格:100mg)为受试制剂,以辉瑞制药有限公司的枸橼酸西地那非片(R,商品名:万艾可®,规格:100mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康男性体内的生物等效性。
次要目的:观察枸橼酸西地那非片在健康男性受试者中的安全性
[Translation] Primary Objective: To investigate the bioequivalence of Sildenafil Citrate Tablets (T, 100 mg) from Sichuan Yike Pharmaceutical Co., Ltd. and Sildenafil Citrate Tablets (R, trade name: Viagra®, 100 mg) from Pfizer Inc. in healthy male subjects using the test formulation and the reference formulation, according to relevant bioequivalence testing regulations.
Secondary Objective: To observe the safety of Sildenafil Citrate Tablets in healthy male subjects.
/ CompletedNot Applicable 盐酸溴己新片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period crossover bioequivalence study of bromhexine hydrochloride tablets in healthy volunteers after single oral administration on an empty stomach or after a meal
主要目的:
评价中国健康受试者在空腹/餐后状态下单次口服四川依科制药有限公司生产的盐酸溴己新片(规格:8mg)与参比制剂盐酸溴己新片(规格:8mg;商品名:Bisolvon®)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:评价单剂量口服盐酸溴己新片(规格:8mg)在中国健康受试者中的安全性。
[Translation] Primary Objective:
To evaluate the in vivo pharmacokinetic characteristics of bromhexine hydrochloride tablets (strength: 8 mg) produced by Sichuan Yike Pharmaceutical Co., Ltd. and the reference preparation bromhexine hydrochloride tablets (strength: 8 mg; trade name: Bisolvon®) in healthy Chinese volunteers after a single oral dose in the fasting and fed state, and to assess the bioequivalence of the two formulations.
Secondary Objective: To evaluate the safety of a single oral dose of bromhexine hydrochloride tablets (strength: 8 mg) in healthy Chinese volunteers.
100 Clinical Results associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.
0 Patents (Medical) associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.
100 Deals associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.
100 Translational Medicine associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.