[Translation] Study plan for a single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence trial of perindopril amlodipine tablets (III) 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培哚普利氨氯地平片(Ⅲ)(持证商:武汉熙瑞医药科技有限公司)与参比制剂培哚普利氨氯地平片(Ⅲ)(持证商:Les Laboratoires Servier,商品名:开素达®)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。观察受试制剂培哚普利氨氯地平片(Ⅲ)和参比制剂培哚普利氨氯地平片(Ⅲ)在健康受试者中的安全性。
[Translation] The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behaviors of the test preparation Perindopril Amlodipine Tablets (III) (licensed by Wuhan Xirui Pharmaceutical Technology Co., Ltd.) and the reference preparation Perindopril Amlodipine Tablets (III) (licensed by Les Laboratoires Servier, trade name: Kaisuda®) 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 Perindopril Amlodipine Tablets (III) and the reference preparation Perindopril Amlodipine Tablets (III) in healthy subjects was observed.