评价富马酸非索罗定缓释片用于膀胱过度活动症患者的有效性和安全性的随机、双盲、安慰剂对照、多中心临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of fesoterodine fumarate sustained-release tablets in patients with overactive bladder
评价富马酸非索罗定缓释片用于膀胱过度活动症患者的有效性和安全性
[Translation] To evaluate the efficacy and safety of fesoterodine fumarate sustained-release tablets in patients with overactive bladder
中国健康受试者空腹和餐后单次口服阿哌沙班分散片和阿哌沙班片的随机、开放、两序列、两周期、双交叉设计的生物等效性研究
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover design bioequivalence study of fasting and postprandial oral administration of apixaban dispersible tablets and apixaban tablets in Chinese healthy subjects
主要目的:
以上海奥全生物医药科技有限公司提供的阿哌沙班分散片为受试制剂(2.5 mg/片),以Bristol-Myers Squibb Manufacturing Company生产的阿哌沙班片(Eliquis®,2.5mg/片)为参比制剂,比较阿哌沙班分散片和阿哌沙班片在中国健康受试者体内的药代动力学(Pharmacokinetics,PK)行为,评价空腹和餐后口服两种制剂的生物等效性。
次要目的:
1、评价中国健康受试者空腹及餐后单次口服阿哌沙班分散片和阿哌沙班片的安全性。
2、收集受试者服用阿哌沙班分散片后15 min内的感官评估问卷(包含口感、口味以及服药后的余味)。
[Translation] main purpose:
Apixaban dispersible tablets provided by Shanghai Aoquan Biomedical Technology Co., Ltd. were used as the test preparation (2.5 mg/tablet), and Apixaban tablets (Eliquis®, 2.5 mg/tablet) produced by Bristol-Myers Squibb Manufacturing Company ) as a reference preparation, to compare the pharmacokinetics (Pharmacokinetics, PK) behavior of Apixaban Dispersible Tablets and Apixaban Tablets in Chinese healthy subjects, and to evaluate the biological effects of the two preparations on an empty stomach and after meals. Effectiveness.
Secondary purpose:
1. To evaluate the safety of apixaban dispersible tablets and apixaban tablets taken by Chinese healthy subjects on an empty stomach and after a meal.
2. Collect the sensory evaluation questionnaires (including mouthfeel, taste and aftertaste after taking the medicine) within 15 minutes after the subjects took the Apixaban Dispersible Tablets.
一项随机、开放、单剂量、两周期、双交叉、餐后给药临床研究,评价硝苯地平缓释片与Adalat® GITS在中国健康成年受试者中的生物等效性
[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover, postprandial clinical study to evaluate the bioequivalence of nifedipine extended-release tablets and Adalat® GITS in healthy Chinese adult subjects
主要目的:以广州玻思韬控释药业有限公司提供的硝苯地平缓释片(30mg/片)为受试制剂,按生物等效性试验的有关规定,与Bayer AG 持有的硝苯地平控释片(商品名:Adalat® GITS,规格:30mg/片)为参比制剂,进行生物等效性试验,比较两种制剂在餐后条件下单次给药的生物等效性。
次要目的:评估单剂口服受试制剂(硝苯地平缓释片,T)和参比制剂(Adalat® GITS,R)在中国健康成年受试者中的安全性。
[Translation] Main purpose: Take nifedipine sustained-release tablets (30mg/tablet) provided by Guangzhou Bositao Controlled-Release Pharmaceutical Co., Ltd. as the test preparation. Dipine controlled-release tablets (trade name: Adalat® GITS, specification: 30 mg/tablet) were used as reference preparations, and a bioequivalence test was conducted to compare the bioequivalence of the two preparations under postprandial conditions for a single dose.
Secondary objective: To evaluate the safety of single-dose oral test preparation (Nifedipine Extended-Release Tablets, T) and reference preparation (Adalat® GITS, R) in healthy Chinese adult subjects.
100 Clinical Results associated with Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.
100 Deals associated with Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.