[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover controlled design was used to evaluate the bioequivalence of pinaverium bromide tablets after a single oral dose in healthy Chinese subjects.
主要目的:以浙江恒研医药科技有限公司提供的匹维溴铵片为受试制剂,按生物等效性试验的有关规定,与Abbott Laboratories Limited持证的匹维溴铵片(商品名:Dicetel®/得舒特®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂匹维溴铵片和参比制剂匹维溴铵片(Dicetel®/得舒特®)在健康受试者中的安全性。
[Translation] Main purpose: Using Pinaverium Bromide Tablets provided by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of Pinaverium Bromide Tablets (trade name: Dicetel®/Deshute®, reference preparation) certified by Abbott Laboratories Limited were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Pinaverium Bromide Tablets and the reference preparation Pinaverium Bromide Tablets (Dicetel®/Deshute®) in healthy subjects.