[Translation] A single-center, open-label, randomized, single-dose, three-period, three-sequence, partially repeated crossover bioequivalence study to evaluate the bioequivalence of the test formulation, pravastatin sodium tablets (strength: 40 mg), and the reference formulation (PRAREDUCT®) (strength: 40 mg) in healthy adult participants in the fasting and fed state.
主要试验目的:
研究空腹和餐后状态下单次口服受试制剂普伐他汀钠片(规格:40 mg,第一三共制药(上海)有限公司生产)与参比制剂普伐他汀钠片(PRAREDUCT®,规格:40 mg;Daiichi Sankyo Europe GmbH生产)在健康参与者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:
研究受试制剂普伐他汀钠片(规格:40 mg)和参比制剂普伐他汀钠片(PRAREDUCT®)(规格:40 mg)在健康参与者中的安全性
[Translation] Main purpose of the study:
To study the pharmacokinetic characteristics of the test preparation pravastatin sodium tablets (specification: 40 mg, produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) and the reference preparation pravastatin sodium tablets (PRAREDUCT®, specification: 40 mg; produced by Daiichi Sankyo Europe GmbH) in healthy participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state.
Secondary purpose of the study:
To study the safety of the test preparation pravastatin sodium tablets (specification: 40 mg) and the reference preparation pravastatin sodium tablets (PRAREDUCT®) (specification: 40 mg) in healthy participants