Shandong Huasu Pharmaceutical Co., Ltd.

Main study purpose: According to the relevant provisions of bioequivalence test, glipizide tablets (trade name: Minidiab®; specification: 5mg) with Pfizer Italia s.r.l. as the licensee were selected as the reference preparation, and the test preparation glipizide dispersible tablets (specification: 5mg) produced and provided by Shandong Huasu Pharmaceutical Co., Ltd. were subjected to human bioequivalence test under fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of Chinese healthy subjects after oral administration of the test preparation glipizide dispersible tablets (specification: 5mg) and the reference preparation glipizide tablets (trade name: Minidiab®; specification: 5mg).

Main research purpose: According to the relevant provisions of bioequivalence test, glipizide tablets (trade name: Minidiab, specification: 5mg) with Pfizer Italia s.r.l. as the licensee were selected as the reference preparation, and the test preparation glipizide dispersible tablets (specification: 5mg) produced by Shandong Huasu Pharmaceutical Co., Ltd. were conducted on the human bioequivalence pre-test of fasting and postprandial administration, and the pharmacokinetic characteristics of the test preparation and the reference preparation under fasting and postprandial administration conditions were estimated, so as to provide a certain reference basis for the design of formal trials. Secondary research purpose: To observe the safety of oral administration of the test preparation glipizide dispersible tablets (specification: 5mg) and the reference preparation glipizide tablets (trade name: Minidiab, specification: 5mg) by healthy volunteers.

A single-center, randomized, open, three-period, semi-repeated crossover, single-dose design was used to compare the differences in absorption extent and absorption rate between benidipine hydrochloride tablets (specification: 4 mg) produced by Shandong Huasu Pharmaceutical Co., Ltd. and benidipine hydrochloride tablets (trade name: CONIEL®/Colirol®, specification: 4 mg) produced by Kyowa Hakko Kirin Co., Ltd. under fasting and postprandial administration conditions in healthy Chinese people, and to evaluate the safety of benidipine hydrochloride tablets produced by Shandong Huasu Pharmaceutical Co., Ltd.