[Translation] A single-dose, fasting/postprandial, randomized, open-label, two-dose, four-cycle, full-repetition crossover bioequivalence study of atorvastatin calcium tablets in healthy subjects
主要研究目的:以湖南天济草堂制药股份有限公司研制的阿托伐他汀钙片(20mg/片)为受试制剂,以Pfizer Ireland Pharmaceuticals生产、Parke-Davis Division of Pfizer Inc分装的阿托伐他汀钙片(20mg/片,立普妥®)为参比制剂,评估受试制剂和参比制剂分别在空腹和餐后状态下给药时的相对生物利用度和生物等效性。 次要研究目的:观察受试制剂在健康受试者中的安全性。
[Translation] Main research purpose: Take atorvastatin calcium tablets (20mg/tablet) developed by Hunan Tianji Caotang Pharmaceutical Co., Ltd. Statin calcium tablets (20 mg/tablet, Lipitor®) were used as the reference preparation to evaluate the relative bioavailability and bioequivalence of the test preparation and the reference preparation when administered in the fasting and postprandial states, respectively. Secondary study objective: To observe the safety of the test preparation in healthy subjects.