妥洛特罗贴剂在健康受试者中随机、开放、单剂量、两制剂、两周期、两序列交叉空腹状态下生物等效性预试验
[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence pilot study of tulobuterol patch in healthy subjects under fasting conditions
主要目的:按照生物等效性试验的相关规定,以浙江海阁堂医药有限公司研制的妥洛特罗贴剂(1 mg/贴)为受试制剂,以日东电工株式会社生产的妥洛特罗贴剂(商品名:阿米迪®,1 mg/贴)为参比制剂,各服用1mg后根据妥洛特罗的体内经时过程,估算其药代动力学参数,初步评估两制剂是否具有生物等效性,为正式试验的方案设计提供修订依据;初步了解药物的药代动力学特性,为正式试验采血点设置提供依据;同时了解药物的浓度范围,为正式试验检测方法学的优化提供参考依据。
次要目的:评价妥洛特罗贴剂在健康受试者体内的安全性、皮肤粘附性和皮肤刺激性。
[Translation] Main purpose: According to the relevant provisions of the bioequivalence test, the tulobuterol patch (1 mg/patch) developed by Zhejiang Haigetang Pharmaceutical Co., Ltd. was used as the test preparation, and the tulobuterol patch (trade name: Amidie®, 1 mg/patch) produced by Nitto Denko Corporation was used as the reference preparation. After taking 1 mg of each, the pharmacokinetic parameters were estimated according to the in vivo time course of tulobuterol, and the two preparations were preliminarily evaluated to see whether they were bioequivalent, providing a basis for revising the design of the formal test plan; the pharmacokinetic properties of the drug were preliminarily understood, providing a basis for setting up the blood collection points for the formal test; and the concentration range of the drug was understood, providing a reference for optimizing the detection methodology of the formal test.
Secondary purpose: To evaluate the safety, skin adhesion and skin irritation of the tulobuterol patch in healthy subjects.
100 Clinical Results associated with Zhejiang Haigetang Pharmaceutical Co., Ltd.
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