Hayao Group Sanjing Pharmaceutical Nuojie Co., Ltd.

The main purpose of the study is to use Cephalexin Tablets produced by Heilongjiang Nuojie Pharmaceutical Co., Ltd. as the test preparation and Cephalexin Tablets produced by Teva Pharmaceuticals USA.lnc as the reference preparation, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle crossover study. Secondary purpose of the study: to observe the safety of Cephalexin Tablets in healthy subjects.

The main purpose of the study was to use Cephalexin Tablets (Specification: 0.25 g/tablet) produced by Heilongjiang Nuojie Pharmaceutical Co., Ltd. as the test preparation and Cephalexin Tablets (Specification: 0.25 g/tablet) produced by Teva Pharmaceuticals USA.lnc as the reference preparation, and to evaluate the bioequivalence of the two preparations in the fasting and fed state in a single-center, randomized, open, single-dose, two-cycle crossover study. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy subjects.

Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test preparation ibuprofen granules provided by Heilongjiang Nuojie Pharmaceutical Co., Ltd. and the reference preparation ibuprofen granules (Kaken Pharmaceutical Co., Ltd., trade name: Brufen) in healthy subjects after oral administration under fasting/postprandial conditions were compared to evaluate the bioequivalence of the two preparations.