[Translation] A single-center, single-dose, randomized, open-label, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of ibuprofen tablets in healthy subjects
主要研究目的:通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单次口服受试制剂布洛芬片(规格:0.2 g,华东医药(西安)博华制药有限公司生产)与参比制剂布洛芬片(商品名:Motrin IB,规格:0.2 g,Perrigo R ANDD 持证)后的体内药代动力学特征,评价两制剂的生物等效性。
次要研究目的:评价单次口服布洛芬片 0.2 g 受试制剂及参比制剂在中国健康受试者中的安全性
[Translation] Main research purpose: Through fasting/postprandial test studies, investigate the in vivo pharmacokinetic characteristics of the test preparation ibuprofen tablets (specification: 0.2 g, produced by Huadong Medicine (Xi'an) Bohua Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen tablets (trade name: Motrin IB, specification: 0.2 g, Perrigo R ANDD certified) after a single oral administration of the test preparation ibuprofen tablets (specification: 0.2 g, produced by Huadong Medicine (Xi'an) Bohua Pharmaceutical Co., Ltd.) to healthy Chinese subjects under fasting/postprandial conditions, and evaluate the bioequivalence of the two preparations.
Secondary research purpose: Evaluate the safety of a single oral administration of 0.2 g of the test preparation and the reference preparation of ibuprofen tablets in healthy Chinese subjects