Guoyao Group Rongsheng Pharmaceutical Co. Ltd.

This study aimed to investigate the pharmacokinetic characteristics of nicorandil tablets (5 mg) produced by Rongsheng Pharmaceutical Co., Ltd. of China National Pharmaceutical Group after oral administration on an empty stomach or after meals, and to use nicorandil tablets (Sigma®, 5 mg) certified by Chugai Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

A single-center, randomized, open, single-dose, two-period, self-crossover design was used to evaluate the pharmacokinetic parameters of bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Sinopharm Rongsheng Pharmaceutical Co., Ltd. and bisoprolol amlodipine tablets (trade name: Kangxinan®, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) certified by Merck Kft. The bioequivalence of the reference preparation and the test preparation in humans under fasting and fed conditions was evaluated.

This study aims to study the pharmacokinetic characteristics of a single-dose oral fasting and postprandial dose of Asartan Potassium Tablets (80 mg) licensed by Sinopharm Rongsheng Pharmaceutical Co., Ltd., and Asartan Potassium Tablets (Edabib®, 80 mg) licensed by Takeda Pharma A/S as the reference preparation, compare the pharmacokinetic parameters of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the test preparation and the reference preparation in healthy subjects.