/ CompletedNot Applicable 枸橼酸西地那非口崩片在中国健康受试者中的单次给药、随机、开放、两序列、两周期、空腹条件下的生物等效性试验
[Translation] A single-dose, randomized, open-label, two-sequence, two-period, fasting bioequivalence study of sildenafil citrate orodisintegrating tablets in Chinese healthy volunteers
主要目的：本研究以河南君善生物技术有限公司持证、济南高华制药有限公司生产的枸橼酸西地那非口崩片（规格：50mg）为受试制剂，以 Upjohn EESV 持证、Fareva Amboise 生产的枸橼酸西地那非口崩片（商品名：万艾可®Viagra®，规格：50mg）为参比制剂，评估受试制剂和参比制剂在空腹条件下的生物等效性。
次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study used sildenafil citrate orodisintegrating tablets (specification: 50 mg) licensed by Henan Junshan Biotechnology Co., Ltd. and produced by Jinan Gaohua Pharmaceutical Co., Ltd. as the test preparation, and sildenafil citrate orodisintegrating tablets (trade name: Viagra®, specification: 50 mg) licensed by Upjohn EESV and produced by Fareva Amboise as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting conditions.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 盐酸达泊西汀片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of dapoxetine hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions
主要目的：本研究以河南君善生物技术有限公司提供的盐酸达泊西汀片（生产单位：济南高华制药有限公司 规格：60mg）为受试制剂，以Menarini-Von Heyden GmbH生产的盐酸达泊西汀片（持证商：Berlin-Chemie AG，商品名为：必利劲PRILIGY 规格：60mg）为参比制剂，评估受试制剂和参比制剂在空腹和餐后条件下的生物等效性。
次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study used dapoxetine hydrochloride tablets provided by Henan Junshan Biotechnology Co., Ltd. (manufacturer: Jinan Gaohua Pharmaceutical Co., Ltd., specification: 60 mg) as the test preparation and dapoxetine hydrochloride tablets produced by Menarini-Von Heyden GmbH (licensed manufacturer: Berlin-Chemie AG, trade name: PRILIGY, specification: 60 mg) as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting and postprandial conditions.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 乌帕替尼缓释片（15 mg）在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of upadacitinib extended-release tablets (15 mg) in healthy Chinese subjects under fasting and fed conditions
主要研究目的：以AbbVie Deutschland GmbH & Co. KG持证的乌帕替尼缓释片（商品名：Rinvoq® (瑞福®)）为参比制剂，以河南君善生物技术有限公司生产的乌帕替尼缓释片为受试制剂，通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。
次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the upadacitinib extended-release tablets (trade name: Rinvoq®) certified by AbbVie Deutschland GmbH & Co. KG as the reference preparation and the upadacitinib extended-release tablets produced by Henan Junshan Biotechnology Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Henan Junshan Biotechnology Co., Ltd.
0 Patents (Medical) associated with Henan Junshan Biotechnology Co., Ltd.
100 Deals associated with Henan Junshan Biotechnology Co., Ltd.
100 Translational Medicine associated with Henan Junshan Biotechnology Co., Ltd.
