[Translation] A single-center, open-label, randomized, single-dose evaluation of the test preparation pravastatin sodium tablets (strength: 40 mg) and the reference preparation (PRAREDUCT®) (strength: 40 mg) in healthy adult participants under fasting and postprandial conditions , three-cycle, three-sequence, partially repeated crossover bioequivalence trial
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 test purpose:
Study the single oral administration 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) in the fasting and postprandial state : 40 mg; produced by Daiichi Sankyo Europe GmbH) in healthy participants to evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states.
Secondary test purpose:
Study the safety of the test preparation pravastatin sodium tablets (strength: 40 mg) and the reference preparation pravastatin sodium tablets (PRAREDUCT®) (strength: 40 mg) in healthy participants