[Translation] Study protocol of single-center, randomized, open-label, two-preparation, single-dose, two-cycle, double-crossover fasting/postprandial 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] Pharmacokinetic parameters were used as the primary endpoint evaluation index to compare the oral administration of the test preparation Perindopril Amlodipine Tablets (Ⅲ) (license holder: Wuhan Xirui Pharmaceutical Technology Co., Ltd.) and The pharmacokinetic behavior of the reference preparation Perindopril and Amlodipine Tablets (Ⅲ) (licensee: Les Laboratoires Servier, trade name: Kaisuda®) in healthy subjects was evaluated. Bioequivalence. Observe the safety of the test preparation Perindopril Amlodipine Tablets (Ⅲ) and the reference preparation Perindopril Amlodipine Tablets (Ⅲ) in healthy subjects.