/ CompletedNot Applicable 磷酸芦可替尼片在中国健康受试者中随机、开放、单次给药、两制剂、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, single-dose, two-formulation, two-period, double-crossover bioequivalence study of ruxolitinib phosphate tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:评价湖北广济医药科技有限公司的磷酸芦可替尼片(受试制剂,规格:5mg;重庆博腾药业有限公司生产)与Novartis Pharma Stein AG,瑞士生产的磷酸芦可替尼片(参比制剂,规格:5mg,商品名:Jakavi(捷恪卫))在中国健康受试者中空腹/餐后单次给药(5mg)条件下的药代动力学特征,评价受试制剂和参比制剂的生物等效性。
次要目的:评价中国健康受试者空腹和餐后条件下单次服用5mg受试制剂磷酸芦可替尼片和5mg参比制剂磷酸芦可替尼片(Jakavi(捷恪卫))的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetic characteristics of ruxolitinib phosphate tablets (test preparation, specification: 5 mg; produced by Chongqing Boteng Pharmaceutical Co., Ltd.) produced by Hubei Guangji Pharmaceutical Technology Co., Ltd. and ruxolitinib phosphate tablets (reference preparation, specification: 5 mg, trade name: Jakavi) produced by Novartis Pharma Stein AG, Switzerland under the conditions of single fasting/fed administration (5 mg) in healthy Chinese subjects, and to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary objective: To evaluate the safety of single administration of 5 mg test preparation ruxolitinib phosphate tablets and 5 mg reference preparation ruxolitinib phosphate tablets (Jakavi) under fasting and fed conditions in healthy Chinese subjects.
/ CompletedNot Applicable 替硝唑片(500mg)在中国健康受试者中随机开放餐后单剂量两周期双交叉生物等效试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of tinidazole tablets (500 mg) in healthy Chinese subjects after a single dose of food
主要研究目的:本研究以,湖北广济药业股份有限公司生产的替硝唑片(规格0.5g),Mission Pharmacal Company生产,Mikart inc Atlanta GA持证的替硝唑片(商品名:TINDAMAX®,规格:500mg/片)为参比制剂,评估受试制剂和参比制剂在餐后条件下给药时的生物等效性。次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary study objective: This study uses tinidazole tablets (specification 0.5g) produced by Hubei Guangji Pharmaceutical Co., Ltd. and tinidazole tablets (trade name: TINDAMAX®, specification: 500mg/tablet) produced by Mission Pharmacal Company and licensed by Mikart inc Atlanta GA as reference preparations to evaluate the bioequivalence of the test preparation and the reference preparation when administered under postprandial conditions. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ RecruitingNot Applicable 恩替卡韦分散片在健康受试者中随机、开放、单剂量、两周期、两交叉、空腹状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-period, two-crossover, fasting bioequivalence study of entecavir dispersible tablets in healthy subjects
以湖北广济药业股份有限公司提供的恩替卡韦分散片为受试制剂,按生物等效性试验的有关规定,以BRISTOLMYERS SQUIBB生产的恩替卡韦片(BARACLUDE ® )为参比制剂对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
[Translation] Entecavir dispersible tablets provided by Hubei Guangji Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of the bioequivalence test, entecavir tablets (BARACLUDE ® ) produced by BRISTOLMYERS SQUIBB were used as the reference preparation to compare the relative bioavailability in healthy humans and investigate the human bioequivalence of the two preparations.
100 Clinical Results associated with Hubei Guangji Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hubei Guangji Pharmaceutical Co., Ltd.
100 Deals associated with Hubei Guangji Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hubei Guangji Pharmaceutical Co., Ltd.