[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of 75 mg polyprene zinc granules in healthy subjects under fasting conditions
主要研究目的
研究空腹状态下单次口服受试制剂T(聚普瑞锌颗粒75mg/袋,吉林省博大伟业制药有限公司生产)与参比制剂R(聚普瑞锌颗粒Promac ®,75 mg/袋,ZERIA新药工业株式会社生产)在健康受试者体内的药代动力学特征,评价空腹状态下口服两种制剂的生物等效性。
次要研究目的
评价受试制剂T与参比制剂R在健康受试者中的安全性。
[Translation] Main study objectives
To study the pharmacokinetic characteristics of the test preparation T (Poprezinc granules 75 mg/bag, produced by Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference preparation R (Poprezinc granules Promac ®, 75 mg/bag, produced by ZERIA Pharmaceutical Industry Co., Ltd.) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions.
Secondary study objectives
To evaluate the safety of the test preparation T and the reference preparation R in healthy subjects.