Hayao Group Sanjing Pharmaceutical Nuojie Co., Ltd.

Primary Study Objectives: To investigate the relative bioavailability of a single oral dose of the test formulation and the reference formulation in healthy Chinese adult subjects, analyze the pharmacokinetic parameters of the two formulations, and evaluate their bioequivalence, providing a basis for drug application and clinical use. Secondary Study Objectives: To evaluate the safety of a single oral dose of the test formulation and the reference formulation in healthy Chinese adult 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.