Jilin Aodong Pharmaceutical Industry Group Yanji Co. Ltd.

Main research purpose: According to the relevant provisions of bioequivalence test, amlodipine besylate tablets (trade name: Norvasc, specification: 5mg) of Pfizer Pharmaceuticals Co., Ltd. as the licensee were selected as the reference preparation, and the test preparation amlodipine besylate tablets (specification: 5mg) produced by Jilin Aodong Pharmaceutical Group Yanji Co., Ltd. were subjected to human bioequivalence test on 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 research purpose: To observe the safety of oral administration of the test preparation amlodipine besylate tablets (specification: 5mg) and the reference preparation amlodipine besylate tablets (trade name: Norvasc, specification: 5mg) by healthy volunteers.

To ensure the safety of the drug after it is marketed, a safety study involving at least 300 patients with a dosing cycle of 24 weeks should be completed. Based on the safety data of 24 weeks of dosing in this clinical trial, the course of treatment, precautions and other relevant content that may be involved in the instructions should be revised and improved in a scientific and reasonable manner.