Shanghai Sine Pharmaceutical Co. Ltd.

In this study, acetaminophen anhydrous swallowing granules (0.25 g) produced by Shanghai Shanghai Pharmaceuticals Xinyi Pharmaceutical Co., Ltd. were used as the test preparation, and acetaminophen granules (direct administration) (250 mg) (trade name: ben-u-ron®) produced by Bene-Arzneimittel GmbH were used as the reference preparation. The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting and postprandial conditions were investigated to evaluate the bioequivalence of the two preparations.

Main objective: To compare the absorption rate and extent of Nicorandil tablets provided by Shandong Xinyi Pharmaceutical Co., Ltd. with those of Nicorandil tablets certified by Chugai Pharmaceutical Co., Ltd. in healthy human bodies according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.

The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behavior of the test preparation digoxin tablets (manufacturer: Shanghai SPH Pharmaceuticals Co., Ltd.) and the reference preparation digoxin tablets (licensed manufacturer: Concordia Pharmaceuticals Inc, trade name: LANOXIN) in healthy subjects after oral administration under fasting/postprandial conditions to evaluate the bioequivalence of the two preparations. The safety of the two preparations was also observed.