Tianjin Junan Biopharmaceutical Co Ltd.

Healthy volunteers were used as test subjects, and a randomized self-crossover control trial method was adopted. Omeprazole enteric-coated capsules (trade name: Losec®, specification: 20 mg) were used as the reference preparation, and omeprazole enteric-coated capsules (specification: 20 mg) produced by Tianjin Junan Biopharmaceutical Co., Ltd. were used as the test preparation. According to the relevant bioequivalence test regulations, the bioequivalence of the test preparation and the reference preparation in Chinese healthy volunteers in the postprandial state was evaluated.

Primary objective: To evaluate the bioequivalence of gliclazide extended-release tablets (30 mg) produced by Tianjin Junan Biopharmaceutical Co., Ltd. and gliclazide extended-release tablets (DIAMICRON®, 30 mg) produced by Les Laboratoires Servier in healthy Chinese subjects. Secondary objective: To observe the safety of the test and reference formulations of gliclazide extended-release tablets in healthy Chinese subjects.