[Translation] Single-center, randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial of nifedipine extended-release tablets in healthy subjects
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:乐声药业石家庄有限公司)与参比制剂硝苯地平缓释片(持证商:Bayer Hi spani a, S. L.商品名:Adalat?retad)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。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] Pharmacokinetic parameters were used as the primary endpoint evaluation index to compare the oral administration of the test preparation nifedipine sustained-release tablets (manufacturer: Roxy Pharmaceutical Shijiazhuang Co., Ltd.) and the reference preparation nifedipine in the fasting/postprandial state. The pharmacokinetic behavior of sustained-release tablets (licensee: Bayer Hi spania, S. L. Trade name: Adalat?retad) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations. Observe the safety of the test preparation nifedipine sustained-release tablets and the reference preparation nifedipine sustained-release tablets in healthy subjects.