[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-formulation, two-sequence, two-cycle crossover bioequivalence study of ibuprofen suspension in Chinese healthy adult subjects.
主要研究目的:
考察单次口服200mg(空腹/餐后)受试制剂布洛芬混悬液(规格:100mL:2g,成都倍特得诺药业有限公司生产)与参比制剂布洛芬混悬液(美林®,规格:100mL:2g,上海强生制药有限公司生产),在中国健康人体内的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价受试制剂和参比制剂单次口服200mg(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Main research purposes:
Investigate a single oral administration of 200 mg (fasting/after meals) of the test preparation ibuprofen suspension (specification: 100 mL: 2g, produced by Chengdu Beidenuo Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen suspension (U.S. Lin®, specification: 100mL:2g, produced by Shanghai Johnson & Johnson Pharmaceutical Co., Ltd.), the relative bioavailability in healthy Chinese people, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations, as Provide reference basis for drug declaration and clinical use.
Secondary research purpose:
To evaluate the safety of the test preparation and reference preparation in a single oral administration of 200 mg (fasting/after meals) in Chinese adult healthy subjects.