地奈德乳膏的生物等效性试验(剂量持续时间-效应研究/关键性生物等效性试验/药代动力学对比研究)
[Translation] Bioequivalence test of desonide cream (dose duration-effect study/key bioequivalence test/pharmacokinetic comparative study)
1)剂量持续时间-效应研究:以健康受试者为研究对象,以Perrigo New York Inc/Padagis US LLC持证的地奈德乳膏(规格:0.05%,商品名:DESONIDE)为试验用药,通过观测收缩皮肤血管,致使皮肤变白的作用,探索达到半数最大效应(Emax)的剂量持续时间(ED50);
2)关键性生物等效性试验:以健康受试者为研究对象,以海南全盈药业有限公司持有的地奈德乳膏(规格:0.05%)为受试制剂,Perrigo New York Inc/Padagis US LLC持证的地奈德乳膏(规格:0.05%,商品名:DESONIDE)为参比制剂,通过比较收缩皮肤血管,致使皮肤变白的作用,评价受试制剂与参比制剂是否具有生物等效性;
3)药代动力学对比研究:以健康受试者为研究对象,以海南全盈药业有限公司持有的地奈德乳膏(规格:0.05%)为受试制剂,Perrigo New York Inc/Padagis US LLC持证的地奈德乳膏(规格:0.05%,商品名:DESONIDE)为参比制剂,通过药代动力学对比研究,评价受试制剂与参比制剂的体内暴露。
[Translation] 1) Dose duration-response study: Healthy subjects were used as the research object, and Desonide cream (specification: 0.05%, trade name: DESONIDE) licensed by Perrigo New York Inc/Padagis US LLC was used as the experimental drug. By observing the effect of constricting skin blood vessels and causing skin whitening, explore the dose duration (ED50) to achieve half of the maximum effect (Emax);
2) Key bioequivalence test: Healthy subjects were used as the research object, and desonide cream (specification: 0.05%) held by Hainan Quanying Pharmaceutical Co., Ltd. was used as the test preparation. Perrigo New York Inc. /Desonide cream (specification: 0.05%, trade name: DESONIDE) licensed by Padagis US LLC is used as the reference preparation. By comparing the effects of shrinking blood vessels in the skin and causing skin whitening, evaluate whether the test preparation and the reference preparation are effective. are bioequivalent;
3) Pharmacokinetic comparative study: Healthy subjects were used as the research object, and desonide cream (specification: 0.05%) held by Hainan Quanying Pharmaceutical Co., Ltd. was used as the test preparation, and Perrigo New York Inc/ Desonide cream (specification: 0.05%, trade name: DESONIDE) licensed by Padagis US LLC was used as the reference preparation, and the in vivo exposure of the test preparation and the reference preparation was evaluated through a comparative pharmacokinetic study.
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