[Translation] A single-center, single oral dose, randomized, open-label, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of ibuprofen tablets in healthy research participants
主要研究目的:通过空腹/餐后试验研究,考察中国健康研究参与者在空腹/餐后条件下单次口服受试制剂布洛芬片(规格:0.2 g,哈尔滨泰华药业股份有限公司研发)与参比制剂布洛芬片(商品名:Motrin IB ®,规格:0.2 g,Johnson and Johnson Consumer Inc McNeil Consumer Healthcare Division持证的)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研究参与者中的安全性。
[Translation] Primary study objective: To investigate the in vivo pharmacokinetic characteristics of the test preparation ibuprofen tablets (specification: 0.2 g, developed by Harbin Taihua Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen tablets (trade name: Motrin IB ®, specification: 0.2 g, licensed by Johnson and Johnson Consumer Inc McNeil Consumer Healthcare Division) after a single oral administration of the test preparation ibuprofen tablets (specification: 0.2 g, developed by Harbin Taihua Pharmaceutical Co., Ltd.) in Chinese health research participants under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary study objective: To evaluate the safety of a single oral administration of 0.2 g of the test preparation and the reference preparation of ibuprofen tablets in Chinese health research participants.