[Translation] A randomized, open-label, single-dose, two-formulation, two-period, crossover, fasting/fed bioequivalence study of ibuprofen suspension drops in Chinese healthy subjects
本研究以海南万玮制药有限公司研发的布洛芬混悬滴剂(规格:40 mg:mL)为受试制剂,按生物等效性研究的有关规定,以Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division生产的布洛芬混悬滴剂(规格:50 mg/1.25 mL,商品名:Motrin® )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, ibuprofen suspension drops (specification: 40 mg:mL) developed by Hainan Wanwei Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant regulations of bioequivalence studies, ibuprofen suspension drops (specification: 50 mg/1.25 mL, trade name: Motrin®) produced by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.