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] Randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover fasting and postprandial state bioequivalence trial of ibuprofen suspension in healthy subjects
主要目的:以武汉九珑医药有限责任公司持证(武汉人福药业有限责任公司生产)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] Main purpose: Use the ibuprofen suspension licensed by Wuhan Jiulong Pharmaceutical Co., Ltd. (produced by Wuhan Renfu Pharmaceutical Co., Ltd.) as the test preparation, and use the ibuprofen suspension produced by Shanghai Johnson & Johnson Pharmaceutical Co., Ltd. (Trade name: Merrill Lynch®) is a reference preparation. The pharmacokinetic parameters and relative bioavailability of a single dose of the two preparations under fasting and postprandial conditions were investigated to evaluate whether the two preparations are bioequivalent.
Secondary purpose: To evaluate the safety of test and reference preparations of ibuprofen suspension in Chinese healthy subjects after a single fasting/postprandial oral administration.
100 Clinical Results associated with Wuhan Jiulong Pharmaceutical Co., Ltd.
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