[Translation] Comparative Study on Pharmacokinetics of Desonide Cream in Human
以河北亚东制药有限公司生产的地奈德乳膏(0.05%,持证商:河北新张药股份有限公司)为受试制剂,以Perrigo公司生产的地奈德乳膏(0.05%)为参比制剂,研究局部给药后受试制剂与参比制剂的体内暴露量比,从而评价受试制剂的安全性。
[Translation] Desonide cream (0.05%) produced by Hebei Yadong Pharmaceutical Co., Ltd. (license holder: Hebei Xinzhang Pharmaceutical Co., Ltd.) was used as the test preparation, and desonide cream (0.05%) produced by Perrigo Company was used as the test preparation The reference preparation is to study the in vivo exposure ratio of the test preparation and the reference preparation after topical administration, so as to evaluate the safety of the test preparation.
[Translation] Bioequivalence Study of Desonide Cream in Human
1) 通过初步剂量持续时间-效应的探索研究测定地奈德乳膏参比制剂(0.05%,Perrigo New York Inc)在中国健康受试者中的剂量持续时间-效应关系,确定后续体内生物等效性研究中的剂量持续时间(ED50)和预期满足AUEC值的D2/D1最小比值的受试者比例;
2) 结合初步剂量持续时间-效应探索研究结果,设计合适的研究条件,以河北亚东制药有限公司生产的地奈德乳膏(0.05%,持证商:河北新张药股份有限公司)为受试制剂T,以Perrigo公司生产的地奈德乳膏(0.05%)为参比制剂进行人体生物等效性研究,通过比较两制剂的药效学参数,评价两制剂的生物等效性。
[Translation] 1) Determine the dose-duration-effect relationship of the reference preparation of desonide cream (0.05%, Perrigo New York Inc) in Chinese healthy subjects through the preliminary dose-duration-effect exploration study, and determine the follow-up in vivo biological, etc. The dose duration (ED50) in the efficacy study and the proportion of subjects expected to meet the minimum ratio of D2/D1 of the AUEC value;
2) Combined with the results of the preliminary dose-duration-effect exploration study, design appropriate research conditions. Desonide cream (0.05%, licensed by Hebei Xinzhang Pharmaceutical Co., Ltd.) produced by Hebei Yadong Pharmaceutical Co., Ltd. For the test preparation T, desonide cream (0.05%) produced by Perrigo Company was used as the reference preparation for human bioequivalence study, and the bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters of the two preparations.
利丙双卡因乳膏在健康受试者中的单剂量、空腹、随机、开放、两周期、两交叉生物等效性研究
[Translation] A single-dose, fasting, randomized, open-label, two-cycle, two-crossover bioequivalence study of riprobicaine cream in healthy subjects
本研究以河北亚东制药有限公司生产、河北新张药股份有限公司提供的利丙双卡因乳膏5 g(1 g:利多卡因25 mg和丙胺卡因25 mg)为受试制剂,以AstraZeneca GmbH生产的利丙双卡因乳膏5 g(1 g:利多卡因25 mg和丙胺卡因25 mg,商品名:EMLA®)为参比制剂,评价受试制剂和参比制剂在空腹条件下给药时的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] In this study, lipocaine cream 5 g (1 g: lidocaine 25 mg and prilocaine 25 mg) produced by Hebei Yadong Pharmaceutical Co., Ltd. and provided by Hebei Xinzhang Pharmaceutical Co., Ltd. was used as the test preparation. Using lipocaine cream 5 g (1 g: lidocaine 25 mg and prilocaine 25 mg, trade name: EMLA®) produced by AstraZeneca GmbH as the reference preparation, the test preparations and reference preparations were evaluated in Bioequivalence when administered under fasted conditions. The safety of the test preparation and the reference preparation in healthy subjects was observed.
100 Clinical Results associated with Hebei Xinzhang Pharmaceutical Co., Ltd.
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100 Deals associated with Hebei Xinzhang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hebei Xinzhang Pharmaceutical Co., Ltd.