[Translation] A single-dose, randomized, open-label, two-formulation, two-sequence, two-period, double-crossover, fasting PK and PD bioequivalence study of miglitol tablets (50 mg) in healthy subjects
主要研究目的:以三和化学研究所株式会社持证的米格列醇片(商品名:Seibule)为参比制剂,以武汉维奥制药有限公司生产的米格列醇片为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉、空腹状态下的临床研究来评价两种制剂在空腹条件下的PK和PD 人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use Miglitol Tablets (trade name: Seibule) certified by Sanwa Chemical Research Institute Co., Ltd. as the reference preparation and Miglitol Tablets produced by Wuhan Via Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the PK and PD human bioequivalence of the two preparations under fasting conditions through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-cycle, double-crossover, fasting clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.