Beijing Jinchengtaier Pharmaceutical Co., Ltd.

The main purpose of the study was to use the bisoprolol amlodipine tablets produced by Beijing Jincheng Taier Pharmaceutical Co., Ltd. as the test preparation and the bisoprolol amlodipine tablets (Kangxinan®) certified by Merck Kft as the reference preparation, and to evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, two-sequence, two-period, double-crossover, fasting and postprandial clinical study. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Primary objective: To compare the differences in the extent and rate of absorption of a single oral dose of bisoprolol fumarate tablets (specification: 5 mg) provided by Beijing Jincheng Taier Pharmaceutical Co., Ltd. and bisoprolol fumarate tablets (trade name: Concor®; specification: 5 mg) certified by Merck Serono GmbH in healthy people under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and fed conditions. Secondary objective: To evaluate the safety and tolerability of a single oral dose of bisoprolol fumarate tablets (specification: 5 mg) provided by Beijing Jincheng Taier Pharmaceutical Co., Ltd. and bisoprolol fumarate tablets (trade name: Concor®; specification: 5 mg) certified by Merck Serono GmbH under fasting and fed conditions.

Main study objectives: To investigate the pharmacokinetic characteristics of a single oral tablet of 1 tablet of 5-adenosylmethionine disulfonate enteric-coated tablets (test preparation T, specification: 0.5g) produced by Beijing Jincheng Taier Pharmaceutical Co., Ltd. and a single oral tablet of 1 tablet of 5-adenosylmethionine disulfonate enteric-coated tablets (reference preparation R, trade name: Sumeta®, specification: 0.5g) certified by ABBOTT LABORATORIES (M) SDN. BHD under the same conditions, evaluate the bioequivalence of the two preparations, and provide a basis for the registration application of the test preparation. Secondary study objectives: To observe the safety of a single oral administration of the test preparation 5-adenosylmethionine disulfonate enteric-coated tablets (specification: 0.5g) or the reference preparation 5-adenosylmethionine disulfonate enteric-coated tablets (trade name: Sumeta®, specification: 0.5g) in healthy subjects in China under fasting and postprandial conditions.