[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence pilot study of ibuprofen suspension in healthy subjects under fasting and fed conditions
以黑龙江中桂制药有限公司生产的布洛芬混悬液为受试制剂,以上海强生制药有限公司生产的布洛芬混悬液(商品名:美林®)为参比制剂,考察空腹及餐后条件下布洛芬混悬液的药代动力学参数,验证血药浓度分析方法以及采血时间、采样量等的合理性,初步评价两种制剂的生物等效性和个体内变异系数。
次要目的:评价中国健康受试者单次空腹/餐后口服布洛芬混悬液受试制剂和参比制剂后的安全性。
[Translation] The ibuprofen suspension produced by Heilongjiang Zhonggui Pharmaceutical Co., Ltd. was used as the test preparation, and the ibuprofen suspension (trade name: Meilin®) produced by Shanghai Johnson Pharmaceutical Co., Ltd. was used as the reference preparation. The pharmacokinetic parameters of ibuprofen suspension under fasting and postprandial conditions were investigated, the rationality of the blood drug concentration analysis method, blood sampling time, sampling volume, etc. were verified, and the bioequivalence and intra-individual coefficient of variation of the two preparations were preliminarily evaluated.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of ibuprofen suspension after a single fasting/postprandial oral administration in healthy Chinese subjects.