[Translation] A randomized, open-label, single-dose, two-period, two-crossover bioequivalence study of nifedipine controlled-release tablets in healthy participants, under fasting and postprandial conditions.
主要目的:以山东鲁抗医药集团赛特有限责任公司研制的硝苯地平控释片(规格:30 mg)为受试制剂(T),以Bayer AG生产并持证的硝苯地平控释片(30 mg,商品名:拜新同®)为参比制剂(R),考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要目的:评价硝苯地平控释片受试制剂和参比制剂(拜新同®)在健康参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of nifedipine controlled-release tablets (30 mg) developed by Shandong Lukang Pharmaceutical Group Co., Ltd. (T) as the test formulation (T), and nifedipine controlled-release tablets (30 mg, trade name: Adalat®) manufactured and licensed by Bayer AG as the reference formulation (R), under fasting and postprandial administration, and to evaluate whether the two formulations are bioequivalent.
Secondary objective: To evaluate the safety of the test and reference formulations (Adalat®) of nifedipine controlled-release tablets in healthy participants.