[Translation] Single-center, randomized, open-label, two-preparation, single-dose study of nifedipine extended-release tablets in healthy subjects
Drug, two-cycle, double-cross abdominal/postprandial bioequivalence study
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂硝苯地平缓释片(生产厂家:河北山姆士药业有限公司)与参比制剂硝苯地平缓释片(持证商:Bayer Hispania, S.L.,商品名:Adalat® retard)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂硝苯地平缓释片和参比制剂硝苯地平缓释片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation nifedipine sustained-release tablets (manufacturer: Hebei Samshi Pharmaceutical Co., Ltd.) and the reference preparation in the fasting/postprandial state. Pharmacokinetic behavior of nifedipine extended-release tablets (licensee: Bayer Hispania, S.L., trade name: Adalat® retard) in healthy subjects to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation nifedipine extended-release tablets and the reference preparation nifedipine extended-release tablets in healthy subjects.