Hayao Group Sanjing Pharmaceutical Nuojie Co., Ltd.

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.

The purpose of this study is to use ibuprofen granules provided by Harbin Pharmaceutical Group Sanjin Pharmaceutical Nuojie Co., Ltd. as the test preparation, and conduct human bioavailability and bioequivalence tests with ibuprofen suspension (trade name: Meilin, reference preparation) produced by Shanghai Johnson Pharmaceutical Co., Ltd. according to the relevant provisions of bioequivalence tests, calculate the relative bioavailability of the test preparation, and compare the bioequivalence of the two preparations.