/ CompletedNot Applicable 布洛芬混悬液在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of ibuprofen suspension in healthy subjects under fasting and fed conditions
主要目的: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,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
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] Primary objective: Using the ibuprofen suspension produced by Heilongjiang Zhonggui Pharmaceutical Co., Ltd. as the test preparation and the ibuprofen suspension (trade name: Meilin®) produced by Shanghai Johnson Pharmaceutical Co., Ltd. as the reference preparation, the pharmacokinetic parameters and relative bioavailability of the two preparations after a single administration in the fasting and postprandial state were investigated to evaluate whether the two preparations are bioequivalent.
Secondary objective: To evaluate the safety of the ibuprofen suspension test preparation and the reference preparation after a single oral administration in fasting/postprandial state in healthy Chinese subjects.
/ CompletedNot Applicable 布洛芬混悬液在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性预试验
[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.
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