/ CompletedNot Applicable 单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计的空腹给药和餐后给药的人体生物等效性研究
[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design of fasting and fed administration in humans
研究单次空腹和餐后口服杭州澳赛诺生物科技有限公司研制、江苏诺泰澳赛诺生物制药股份有限公司生产的磷酸奥司他韦胶囊(75 mg)的药代动力学特征;以Roche S.P.A.生产的磷酸奥司他韦胶囊(达菲®/Tamiflu®,75 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The pharmacokinetic characteristics of oseltamivir phosphate capsules (75 mg) developed by Hangzhou Ausino Biotechnology Co., Ltd. and produced by Jiangsu Nortai Ausino Biopharmaceutical Co., Ltd. after single fasting and postprandial oral administration were studied; oseltamivir phosphate capsules (Tamiflu®/Tamiflu®, 75 mg) produced by Roche S.P.A. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.
三周期部分重复、单次、自身交叉比较健康志愿者空腹和餐后下服用阿托伐他汀钙片20mg生物等效性试验
[Translation] A three-cycle partial-repetition, single-dose, self-crossover bioequivalence study of atorvastatin calcium tablets 20 mg in healthy volunteers taking them on an empty stomach or after a meal
1.健康成年受试者空腹、餐后口服单剂量阿托伐他汀钙片(受试制剂)与原研药—阿托伐他汀钙片(立普妥,参比制剂)后,测定血浆中阿托伐他汀及其代谢物的浓度,研究受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
2.评价中国健康受试者单次口服阿托伐他汀钙片的安全性。
[Translation] 1. After a single dose of atorvastatin calcium tablets (test preparation) and the original drug - atorvastatin calcium tablets (Lipitor, reference preparation) were taken orally by healthy adult subjects on an empty stomach or after meals, the concentrations of atorvastatin and its metabolites in plasma were determined to study the absorption rate and extent of the test preparation and the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
2. To evaluate the safety of a single oral dose of atorvastatin calcium tablets in healthy Chinese subjects.
100 Clinical Results associated with Hangzhou Allsino Chemicals Co., Ltd.
0 Patents (Medical) associated with Hangzhou Allsino Chemicals Co., Ltd.
A Novel Approach to N′,N′-Diarylhydrazides from N′-Arylhydrazides
Author: Li, Jing-Hua ; Yu, Jun ; Wang, Shuguang ; Wen, Jianming ; Wang, Jian
A novel method for conversion of N′-arylhydrazides to N′,N′-diarylhydrazides via aerobic oxidation has been achieved. The aerobic reaction was performed using CuCl2 as a catalyst in NH3·H2O–MeOH to give good yields under mild conditions. The mechanism of the reaction is also discussed.
100 Deals associated with Hangzhou Allsino Chemicals Co., Ltd.
100 Translational Medicine associated with Hangzhou Allsino Chemicals Co., Ltd.