[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of polyprezinc granules (strength: 0.5 g: 75 mg) and the reference formulation (Promac®) (strength: 0.5 g: 75 mg) in healthy adult subjects in the fasting and fed state.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂聚普瑞锌颗粒(规格:0.5 g:75 mg,持证商:吉林省博大伟业制药有限公司)与参比制剂聚普瑞锌颗粒(Promac®,规格:0.5 g:75 mg,持证商:ゼリア新薬工業株式会社)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
[Translation] Main research purpose: To study the single oral administration of the test preparation Polyprex zinc granules (specification: 0.5 g: 75 mg, license holder: Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference preparation Juprex Pharmacokinetics of zinc granules (Promac®, specifications: 0.5 g: 75 mg, licensee: Seiko Shinsui Industrial Co., Ltd.) in healthy subjects, and evaluation of the bioequivalence of two oral formulations in fasting and postprandial states sex.