Harbin Pharmaceutical Group Holding Co., Ltd.

In accordance with the relevant provisions of bioequivalence tests, vonoprazan fumarate tablets (trade name: Walker®, specification: 20 mg) certified by Takeda Pharmaceutical Company Limited were selected as the reference preparation. The test preparation vonoprazan fumarate tablets (specification: 20 mg) produced by Harbin Pharmaceutical Group Technology Center and certified by Harbin Pharmaceutical Group Pharmaceutical Factory No. 6 were subjected to human bioequivalence tests under fasting and postprandial conditions. The differences in the absorption rate and extent of the drug in the test preparation and the reference preparation were compared to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting and postprandial conditions was evaluated. The safety of oral administration of the test preparation vonoprazan fumarate tablets (specification: 20 mg) and the reference preparation vonoprazan fumarate tablets (trade name: Walker®, specification: 20 mg) was observed in healthy subjects.

Compound sulfamethoxazole tablets (400mg/80mg) from the sixth pharmaceutical factory of Harbin Pharmaceutical Group were used as the test preparation, and compound sulfamethoxazole tablets (BACTRIM®, specification 400mg/80mg) marketed by Sun Pharmaceutical Industries Inc were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations under a single administration in the fasting state were investigated to evaluate whether the two preparations were bioequivalent and to evaluate the safety of the two preparations in healthy subjects.

The purpose of this study was to study the pharmacokinetic characteristics of a single fasting oral dose of roxithromycin dispersible tablets (150 mg) developed and produced by Harbin Pharmaceutical Group Pharmaceutical Factory No. 6; using roxithromycin tablets (Rolide®, 150 mg) produced by Opella Healthcare International SAS as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.