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[Translation] Comparative study on human pharmacokinetics of desonide cream
以湖北人福成田药业有限公司生产的地奈德乳膏为受试制剂,Perrigo New York Inc 持证的地奈
德乳膏(0.05%,Perrigo®)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 produced by Hubei Renfu Chengtian Pharmaceutical Co., Ltd. was used as the test preparation.
De cream (0.05%, Perrigo®) was used as the reference preparation to study the in vivo exposure ratio of the test preparation and the reference preparation after topical administration, from
To evaluate the safety of the test preparations.
[Translation] Human Bioequivalence Test of Riprobicaine Cream
1)以湖北人福成田药业有限公司的利丙双卡因乳膏为受试制剂,以 Aspen Pharma Trading Limited 的利丙双卡因乳膏(恩纳®/EMLA®)为参比制剂,比较利丙双卡因乳膏在中国健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
2)评估受试制剂利丙双卡因乳膏在中国健康受试者中的安全性。
[Translation] 1) The test preparation was lipodicaine cream from Hubei Renfu Chengtian Pharmaceutical Co., Ltd., and the reference preparation was lipodicaine cream (Enna®/EMLA®) from Aspen Pharma Trading Limited. To compare the pharmacokinetic behavior of Riprobicaine cream in healthy Chinese subjects and to evaluate the bioequivalence of the two formulations.
2) To evaluate the safety of the test preparation lipodicaine cream in healthy Chinese subjects.
[Translation] Bioequivalence study of desonide cream in humans
1)通过剂量持续时间-效应的探索研究测定地奈德乳膏参比制剂(0.05%、PerrigoNew York Inc生产)在中国健康受试者中的剂量持续时间-效应关系;2)结合剂量持续时间-效应探索试验结果,设计合适的试验条件,进行人体生物等效性试验,通过比较受试制剂与参比制剂的药效学参数,评价两制剂的生物等效性。
[Translation] 1) The dose duration-response relationship of desonide cream reference preparation (0.05%, manufactured by PerrigoNew York Inc) in healthy Chinese subjects was determined by a dose duration-response exploratory study; 2) Combined dose duration - The results of the effect exploration test, design appropriate test conditions, conduct the human bioequivalence test, and evaluate the bioequivalence of the two preparations by comparing the pharmacodynamic parameters of the test preparation and the reference preparation.
100 Clinical Results associated with Hubei Humanwell Chengtian Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hubei Humanwell Chengtian Pharmaceutical Co., Ltd.
100 Deals associated with Hubei Humanwell Chengtian Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hubei Humanwell Chengtian Pharmaceutical Co., Ltd.