[Translation] A single-center, randomized, open-label, four-cycle, two-sequence, fully replicated, single fasting/postprandial dosing bioequivalence study was used.
本研究以福安药业集团庆余堂制药有限公司研发的尼麦角林片(规格:30mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Pfizer Italia S.r.l.生产的尼麦角林片(规格:30mg,商品名:SERMION®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
[Translation] In this study, Nicergoline tablets (specification: 30 mg) developed by Fuan Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd. were used as the test preparation. Tablet (strength: 30 mg, trade name: SERMION®) is the reference preparation, and the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions is evaluated.