Anhui Jiexi Pharmaceutical Co., Ltd.

Primary Study Objective: To evaluate the hypoglycemic effect of miglitol tablets (25 mg, brand name: SEIBULE®, licensee: Sanwa Chemical Research Institute Co., Ltd.) at three doses (25 mg, 25 mg × 2, 25 mg × 3) in healthy human subjects to determine the dosage for a formal human bioequivalence trial. Secondary Study Objective: To evaluate the safety of fasting oral administration of miglitol tablets (25 mg, brand name: SEIBULE®) from Sanwa Chemical Research Institute Co., Ltd. to healthy participants.

Using healthy Chinese subjects as subjects, a self-crossover controlled trial design was employed to determine the plasma concentrations of candesartan and hydrochlorothiazide in healthy subjects over time after administration of the test formulation of candesartan oxaliplatin tablets. Corresponding pharmacokinetic parameters were estimated. Candesartan oxaliplatin tablets (trade name: Blopress®, specification: 16 mg candesartan oxaliplatin and 12.5 mg hydrochlorothiazide per tablet), manufactured by Delpharm Novara S.r.l. and licensed by CHEPLAPHARM Arzneimittel GmbH, were used as a reference to evaluate the bioequivalence between the formulations and to observe the safety of candesartan oxaliplatin tablets in healthy Chinese subjects.

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation miglitol tablets (50 mg, manufactured and licensed by Anhui Jiexi Pharmaceutical Co., Ltd.) and the reference formulation miglitol tablets (SEIBULE®, 50 mg, licensed by Sanwa Chemical Research Institute Co., Ltd.) in healthy adult subjects under fasting conditions. Secondary objective: To observe the safety of a single oral dose of the test and reference formulations of miglitol tablets in healthy adult subjects under fasting conditions.