Shaanxi BAI LU Pharmaceutical Co. Ltd.

Bisoprolol Amlodipine Tablets (specification: 5 mg/5 mg) produced by Shaanxi Bailu Pharmaceutical Co., Ltd. was used as the test preparation, and Bisoprolol Amlodipine Tablets (Kangxin'an®, specification: 5 mg/5 mg) produced by Merck Kft. and Egis Pharmaceuticals Plc was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Vonoprazan fumarate tablets (specification: 20 mg) developed by Shaanxi Bailu Pharmaceutical Co., Ltd. were used as the test preparation, and Vonoprazan fumarate tablets (trade name: Walker®/Vocinti®, specification: 20 mg) produced by Takeda Pharmaceutical Company Limited were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

The valsartan hydrochlorothiazide tablets (specification: 80mg/12.5mg) developed by Shaanxi Bailu Pharmaceutical Co., Ltd. were used as the test preparation, and the valsartan hydrochlorothiazide tablets (trade name: Fu Diovan®, specification: 80mg/12.5mg) licensed by Novartis Pharma Schweiz AG, Switzerland were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.