Shandong Huasu Pharmaceutical Co., Ltd.

Main research purpose: According to the relevant provisions of bioequivalence test, the Bisoprolol Amlodipine Tablets (trade name: Kangxinan®; specification: 5mg bisoprolol fumarate and 5mg amlodipine besylate (calculated as amlodipine)) certified by Merck Kft was selected as the reference preparation, and the Bisoprolol Amlodipine Tablets (specification: 5mg bisoprolol fumarate and 5mg amlodipine besylate (calculated as amlodipine)) produced and provided by Shandong Huasu Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, 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 objective: To observe the safety of oral administration of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) and the reference preparation bisoprolol amlodipine tablets (trade name: Kangxinan®; specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) to healthy subjects.

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.