一项多中心上市后观察性研究,评价多格列艾汀在2型糖尿病患者中的长期用药安全性
[Translation] A multicenter post-marketing observational study to evaluate the long-term safety of dopagliflozin in patients with type 2 diabetes
本研究的主要目的是通过收集多格列艾汀上市后临床用药安全性数据,评价本品在更大样本2型糖尿病人群中的长期用药安全性。
[Translation] The main purpose of this study is to collect post-marketing clinical safety data of dogliflozin and to evaluate the long-term safety of this product in a larger sample of type 2 diabetes population.
利托那韦片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence crossover bioequivalence study of ritonavir tablets in healthy subjects after single oral administration on an empty stomach or after a meal
主要目的:考察中国健康受试者在空腹/餐后条件下单次口服上海迪赛诺生物医药有限公司生产的利托那韦片(规格:100mg)与持证商AbbVie Deutschland GmbH & Co. KG.持有的利托那韦片(Norvir®,规格:100mg)后体内药代动力学特征,评价两种制剂的生物等效性。
次要目的:评价单次口服利托那韦片(规格:100mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of ritonavir tablets (specification: 100 mg) produced by Shanghai Desano Biopharmaceutical Co., Ltd. and ritonavir tablets (Norvir®, specification: 100 mg) held by licensee AbbVie Deutschland GmbH & Co. KG. in healthy Chinese subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of ritonavir tablets (specification: 100 mg) in healthy Chinese subjects after a single oral administration.
一项随机、开放、两序列自身交叉设计,评价空腹和餐后状态下中国健康受试者单次口服拉米夫定替诺福韦片的生物等效性研究
[Translation] A randomized, open-label, two-sequence self-crossover design to evaluate the bioequivalence of a single oral dose of lamivudine-tenofovir tablets in Chinese healthy subjects in the fasting and fed states
主要目的:通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单剂量口服江苏诚康药业有限公司(持有人:上海迪赛诺生物医药有限公司)生产的拉米夫定替诺福韦片(规格:拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg)与持证商为Mylan Laboratories Ltd 的拉米夫定替诺福韦片(商品名:Cimduo®,规格:拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg)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:评价单剂量口服拉米夫定替诺福韦片(规格:拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of Lamivudine-Tenofovir Tablets (Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. (Owner: Shanghai Desano Biopharmaceutical Co., Ltd.) and Lamivudine-Tenofovir Tablets (Trade name: Cimduo®, Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) produced by Mylan Laboratories Ltd. (Trade name: Cimduo®, Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of Lamivudine-Tenofovir Tablets (Specifications: Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg) taken orally as a single dose in healthy Chinese subjects.
100 Clinical Results associated with Shanghai Desano Pharmaceuticals Co. Ltd.
0 Patents (Medical) associated with Shanghai Desano Pharmaceuticals Co. Ltd.
Synthesis Methods of An HIV Integrase Inhibitor Raltegravir
Author: Zhu Jun
Synthesis methods of Raltegravir were summarized and analyzed, possible industrial production method was suggested.
100 Deals associated with Shanghai Desano Pharmaceuticals Co. Ltd.
100 Translational Medicine associated with Shanghai Desano Pharmaceuticals Co. Ltd.