[Translation] A single-center, single oral dose, randomized, open-label, two-sequence, two-cycle, double-crossover, fasting and postprandial state bioequivalence study of ibuprofen suspension 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混悬液(规格:100 mL:2 g,山东辰欣佛都药业股份有限公司研发)与参比制剂布洛芬混悬液(商品名:美林,规格:100 mL:2 g,上海强生制药有限公司生产)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混悬液100 mL: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 experimental research, to investigate the single oral administration of the test preparation ibuprofen suspension (specification: 100 mL: 2 g, Shandong Chenxinfo) to Chinese healthy subjects under fasting/postprandial conditions. Evaluation of the in vivo pharmacokinetic characteristics of ibuprofen suspension (trade name: Merrill Lynch, specification: 100 mL: 2 g, produced by Shanghai Johnson & Johnson Pharmaceutical Co., Ltd.) Bioequivalence of the two preparations.
Secondary study purpose: To evaluate the safety of a single oral dose of ibuprofen suspension 100 mL:2 g test preparation and reference preparation in Chinese healthy subjects.