[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover design bioequivalence study of a single oral dose of amlodipine and atorvastatin calcium tablets in healthy subjects on an empty stomach or after a meal.
主要目的:研究空腹和餐后状态下单次口服受试制剂氨氯地平阿托伐他汀钙片(规格:5mg /10mg,安徽肽渡生物医药科技有限公司持证,裕松源药业有限公司生产)与参比制剂氨氯地平阿托伐他汀钙片(多达一®,规格:5mg/10mg,Pfizer Manufacturing Deutschland GmbH生产)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。 次要目的:空腹和餐后状态下,研究单次口服受试制剂氨氯地平阿托伐他汀钙片和参比制剂氨氯地平阿托伐他汀钙片(多达一®)在健康成年受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation amlodipine atorvastatin calcium tablets (specifications: 5mg/10mg, licensed by Anhui Peptide Biotechnology Co., Ltd., produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (Up to One®, specifications: 5mg/10mg, produced by Pfizer Manufacturing Deutschland GmbH) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To study the safety of the test preparation amlodipine atorvastatin calcium tablets and the reference preparation amlodipine atorvastatin calcium tablets (Up to One®) in healthy adult subjects in the fasting and fed state.