Hainan Guangshengyu Pharmaceutical Co. Ltd.

Primary Study Objectives To investigate the pharmacokinetics of a test cefixime suspension (0.8 g (100 mg/5 ml) (calculated as C₁₆H₁₅N₁₅O₁₅S₂), provided by Hainan Guangshengyu Pharmaceutical Co., Ltd.) compared to a reference cefixime suspension (100 mg/5 ml (calculated as C₁₆H₁₅N₁₅O₁₅S₂), licensed by AMDIPHARM LIMITED) in healthy adult volunteers after a single oral dose in the fasting and fed states, and to evaluate the bioequivalence of the two formulations after fasting and fed oral administration. Secondary Study Objectives To evaluate the safety of a test cefixime suspension (0.8 g (100 mg/5 ml)) compared to a reference cefixime suspension (100 mg/5 ml (calculated as C₁₆H₁₅N₁₅O₁₅S₂), licensed by AMDIPHARM LIMITED) in healthy adult volunteers after a single oral dose in the fasting and fed states.

Healthy subjects were used as test subjects, esomeprazole magnesium sodium bicarbonate dry suspension (II) was the test preparation, and esomeprazole magnesium enteric-coated tablets (Nexium®, 40 mg based on C17H19N3O3S) was the reference preparation. Single and multiple dosing test designs were used to conduct pharmacokinetic and pharmacodynamic comparison tests of the two preparations and the effect of food on the PK parameters of the test preparation: 1. Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple dosing; 2. Compare the pharmacodynamic parameters of the test preparation and the reference preparation after single and multiple dosing; 3. Evaluate the effect of food on the pharmacokinetic parameters of the test preparation; 4. Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Main research purpose: According to the regulations on bioequivalence testing, select Bripipiprazole tablets (trade name: Rexulti, specification: 2 mg) of Otsuka Manufacturing Co., Ltd. as the licensee as the reference preparation. Brippiprazole tablets (specification: 2 mg) produced by Pharmaceutical Co., Ltd. and provided by Hainan Guangshengyu Pharmaceutical Co., Ltd. were subjected to fasting and postprandial administration human bioequivalence tests to compare the absorption rate and absorption rate of the drug in the test preparation. Whether the degree of absorption differs from that of the reference preparation within an acceptable range, the bioequivalence of the two preparations under fasting and postprandial administration conditions was assessed. Secondary research purpose: To observe the safety of the test preparation Bripipiprazole Tablets (specification: 2 mg) and the reference preparation Bripipiprazole Tablets (trade name: Rexulti, specification: 2 mg) taken orally by healthy volunteers.