[Translation] Human Bioequivalence Test of Spironolactone Tablets
以南京双科医药开发有限公司提供的螺内酯片为受试制剂,按生物等效性研究的有关规定,与原研厂Piramal Healthcare UK Limited生产的螺内酯片(商品名:Aldactone®)在健康成年受试者中比较吸收速度及吸收程度的差异,考察两制剂的人体生物等效性
[Translation] Taking the spironolactone tablets provided by Nanjing Shuangke Pharmaceutical Development Co., Ltd. as the test preparation, according to the relevant regulations of the bioequivalence study, the spironolactone tablets (trade name: Aldactone®) produced by the original research factory Piramal Healthcare UK Limited were tested in healthy adults. The differences in absorption rate and degree of absorption were compared among the two preparations, and the human bioequivalence of the two preparations was investigated.
替米沙坦片在中国健康受试者中随机、开放、两制剂、单次给药、餐后三周期三序列部分重复交叉和空腹三周期三序列部分重复交叉的生物等效性研究
[Translation] A randomized, open-label, two-preparation, single-dose, postprandial three-cycle three-sequence partial-repeat crossover bioequivalence study of Telmisartan tablets in Chinese healthy subjects; and a fasting three-cycle three-sequence partial-repeat crossover bioequivalence study.
主要目的:以江苏长江药业有限公司生产、南京双科医药开发有限公司提供的替米沙坦片为受试制剂,按生物等效性研究的有关规定,与Boehringer Ingelheim Ellas A.E公司生产的替米沙坦片(商品名:Micardis®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂替米沙坦片和参比制剂替米沙坦片(Micardis® )在健康受试者中的安全性。
[Translation] Main purpose: Taking Telmisartan tablets produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. and provided by Nanjing Shuangke Pharmaceutical Development Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence studies, it will be compared with the substitute drug produced by Boehringer Ingelheim Ellas A.E. Misartan tablets (trade name: Micardis®, reference preparation) were compared with the absorption speed and degree of absorption in healthy humans to examine the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Telmisartan Tablets and the reference preparation Telmisartan Tablets (Micardis®) in healthy subjects.
注射用去氧氟尿苷治疗晚期胃癌、乳腺癌的单中心、随机、单盲、剂量探索Ⅱa期及人体药代动力学临床试验
[Translation] A single-center, randomized, single-blind, dose-finding phase IIa and human pharmacokinetic clinical trial of deoxyfluridine for injection in the treatment of advanced gastric cancer and breast cancer
(1)初步探索注射用去氧氟尿苷高、中、低不同剂量治疗晚期乳腺癌、胃癌的有效性和安全性; (2)观察乳腺癌、胃癌等患者单剂量和多剂量静脉滴注注射用去氧氟尿苷后药物的体内经时过程,估计其药代动力学参数,并与患者静脉滴注5-FU后的药代动力学参数比较,为临床用药提出指导。
[Translation] (1) Preliminary exploration of the efficacy and safety of high, medium and low doses of deoxyfluridine for injection in the treatment of advanced breast cancer and gastric cancer; (2) Observation of single-dose and multi-dose intravenous drip in patients with breast cancer and gastric cancer The pharmacokinetic parameters of the drug in vivo after deoxyfluridine for injection were estimated and compared with the pharmacokinetic parameters of patients after intravenous infusion of 5-FU to provide guidance for clinical drug use.
100 Clinical Results associated with Nanjing Shuangke Pharmaceutical Development Co., Ltd.
0 Patents (Medical) associated with Nanjing Shuangke Pharmaceutical Development Co., Ltd.
100 Deals associated with Nanjing Shuangke Pharmaceutical Development Co., Ltd.
100 Translational Medicine associated with Nanjing Shuangke Pharmaceutical Development Co., Ltd.