[Translation] A single-center, open-label, randomized, single-dose, four-period, fully repeated, two-sequence, crossover bioequivalence study of fluvastatin sodium extended-release tablets in healthy adult subjects under fasting and fed conditions
主要研究目的:评估受试制剂氟伐他汀钠缓释片80 mg与参比制剂氟伐他汀钠缓释片(来适可®)80 mg在健康成年受试者体内的药代动力学,评价空腹/餐后状态下口服两种制剂的生物等效性。
次要研究目的:观察受试制剂氟伐他汀钠缓释片和参比制剂氟伐他汀钠缓释片(来适可®)在健康人群中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetics of the test preparation fluvastatin sodium sustained-release tablets 80 mg and the reference preparation fluvastatin sodium sustained-release tablets (Lescol®) 80 mg in healthy adult subjects, and to evaluate the bioequivalence of the two preparations taken orally in the fasting/postprandial state.
Secondary purpose of the study is to observe the safety of the test preparation fluvastatin sodium sustained-release tablets and the reference preparation fluvastatin sodium sustained-release tablets (Lescol®) in healthy people.