Hangzhou Muyuan Biomedical Technology Co., Ltd.

Main research purpose: To investigate the single-dose oral (fasting) test preparation of irbesartan and amlodipine tablets [Specification: Each tablet contains 100 mg of irbesartan and 5 mg of amlodipine besylate (calculated as C20H25CIN2O5), Hangzhou Held by Muyuan Biomedical Technology Co., Ltd.] and the reference preparation irbesartan and amlodipine tablets [Aimix®, specifications: each tablet contains 100 mg of irbesartan and 5 mg of amlodipine, owned by Dainippon Sumitomo Co., Ltd. Certificate], relative bioavailability in healthy human subjects in China, analyzing the pharmacokinetic parameters of the two preparations, and evaluating the bioequivalence of the two preparations, to provide a reference basis for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of the test and reference preparations administered as a single oral dose on an empty stomach in Chinese adult healthy subjects.

This study is a pilot study, aimed at studying the pharmacokinetic characteristics of a single fasting and postprandial oral administration of teprenone capsules (50 mg) developed by Hangzhou Muyuan Biotechnology Co., Ltd. and produced by Chengdu Tongde Pharmaceutical Co., Ltd.; using teprenone capsules (50 mg) produced by Eisai (China) Pharmaceuticals Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to provide a reference for the formal trial.

Primary objective: To compare the differences in the degree and rate of absorption of metoclopramide tablets (specification: 10 mg) provided by Hangzhou Muyuan Biopharmaceutical Technology Co., Ltd. and metoclopramide tablets (trade name: Reglan®, specification: 10 mg) licensed by ANI PHARMACEUTICALS INC in healthy Chinese population under fasting and postprandial administration conditions using a single-center, randomized, open, two-dose, two-period crossover, single-dose, fasting and postprandial administration design, and to evaluate bioequivalence. Secondary objective: To evaluate the safety of metoclopramide tablets (specification: 10 mg) provided by Hangzhou Muyuan Biopharmaceutical Technology Co., Ltd. and metoclopramide tablets (trade name: Reglan®, specification: 10 mg) licensed by ANI PHARMACEUTICALS INC under fasting and postprandial conditions.