Hebei Medical University Pharmaceutical Factory

Main study objectives To investigate the relative bioavailability of the test preparation levamlodipine besylate tablets (specification: 5 mg (calculated as levamlodipine), produced by Lesheng Pharmaceutical Shijiazhuang Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®, specification: 10 mg, produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

The pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behavior of the test preparation Nifedipine Sustained Release Tablets (manufacturer: Lesheng Pharmaceutical Shijiazhuang Co., Ltd.) and the reference preparation Nifedipine Sustained Release Tablets (certificate holder: Bayer Hi spani a, S. L. trade name: Adalat?retad) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. The safety of the test preparation Nifedipine Sustained Release Tablets and the reference preparation Nifedipine Sustained Release Tablets in healthy subjects was observed.

Nifedipine sustained-release tablets (II) (specification: 20 mg/tablet) produced by Hebei Medical University Pharmaceutical Factory was used as the test preparation, and nifedipine sustained-release tablets (trade name: Adalat®-L20, specification: 20 mg/tablet) produced by Bayer Pharmaceutical Co., Ltd. (Japan Bayer Pharmaceutical Co., Ltd.) was used as the reference preparation. According to the relevant provisions of bioequivalence test, the bioequivalence of the two preparations in healthy volunteers was investigated.