[Translation] An open-label, randomized, two-sequence, four-cycle, fully replicated crossover design of a bioequivalence trial of a single oral administration of two formulations of atorvastatin calcium tablets in healthy subjects
主要目的:研究空腹单次口服阿托伐他汀钙片受试制剂(20mg/片;Lek S.A., Strykow)与阿托伐他汀钙片参比制剂(LIPITOR®20mg/片;Pfizer Pharmaceuticals Co.,Ltd.)后阿托伐他汀在中国健康受试者体内的药代动力学行为,评价空腹口服两种制剂间的生物等效性。
次要目的:评价中国健康受试者单次口服阿托伐他汀钙片受试制剂和参比制剂后的安全性。
[Translation] Main purpose: To study the test preparation of atorvastatin calcium tablets (20mg/tablet; Lek S.A., Strykow) and the reference preparation of atorvastatin calcium tablets (LIPITOR® 20mg/tablet; Pfizer Pharmaceuticals Co., Ltd.) .) Pharmacokinetic behavior of atorvastatin in healthy Chinese subjects to evaluate the bioequivalence between the two formulations orally administered on an empty stomach.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of atorvastatin calcium tablets after a single oral dose of atorvastatin calcium tablets in Chinese healthy subjects.