Hebei SAMs Pharmaceutical Co., Ltd.

Main purpose: Using levamlodipine besylate tablets (specification: 5 mg) produced by Hebei Sams Pharmaceutical Co., Ltd. as the test preparation, and using amlodipine besylate tablets (trade name: Norvasc, specification: 10 mg) certified by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation, a human bioequivalence test was conducted under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

The ibuprofen sustained-release capsules (trade name: Fenbid®, specification: 0.3 g) certified by Sino-US Tianjin SmithKline Pharmaceutical Co., Ltd. were used as the reference preparation, and the ibuprofen sustained-release capsules (specification: 0.3 g) produced by Hebei Sams Pharmaceutical Co., Ltd. were used as the test preparation. A single-center, open, randomized, single-dose, two-cycle, double-crossover clinical study was conducted to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy adult subjects in China.

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation nifedipine sustained-release tablets (manufacturer: Hebei Sams Pharmaceutical Co., Ltd.) and the reference preparation nifedipine sustained-release tablets (licensed manufacturer: Bayer Hispania, S.L., trade name: Adalat® retard) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation nifedipine sustained-release tablets and the reference preparation nifedipine sustained-release tablets in healthy subjects.