Amlodipine Besylate/Bisoprolol Fumarate

Methods Chinese healthy subjects were used as the test subjects. A self-crossover design was used to determine the time course of blood concentrations of bisoprolol and amlodipine in healthy subjects after administration of bisoprolol amlodipine tablets [specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] developed and produced by Jiangsu Deyuan Pharmaceutical Co., Ltd., and the corresponding pharmacokinetic parameters were estimated. Bisoprolol amlodipine tablets (trade name: Kangxinan®) produced by Egis Pharmaceuticals PLC and licensed by Merk Kft were used as the reference preparation to investigate the relative bioavailability of the test preparation, evaluate the bioequivalence between the preparations, and observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.